Download PDF

Clinical Trial Results:
A Phase 1, Single-Dose, Cross-Over Study Evaluating the Relative Bioavailability and Food Effect of the Bictegravir/Emtricitabine/Tenofovir Alafenamide and Emtricitabine/Tenofovir Alafenamide Pediatric Tablets for Oral Suspension as Compared with the Adult-Strength Tablets

Summary
EudraCT number	2021-000436-62
Trial protocol	Outside EU/EEA
Global end of trial date	24 Nov 2021

Results information
Results version number	v1(current)
This version publication date	15 Dec 2022
First version publication date	15 Dec 2022
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

GS-US-380-4547

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Gilead Sciences

Sponsor organisation address

333 Lakeside Drive, Foster City, CA, United States, 94404

Public contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Scientific contact

Gilead Clinical Study Information Center, Gilead Sciences, GileadClinicalTrials@gilead.com

Is trial part of an agreed paediatric investigation plan (PIP)

Yes

EMA paediatric investigation plan number(s)

EMEA-001766-PIP01-15

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

24 Nov 2021

Is this the analysis of the primary completion data?

Yes

Primary completion date

24 Nov 2021

Global end of trial reached?

Yes

Global end of trial date

24 Nov 2021

Was the trial ended prematurely?

Main objective of the trial

The primary objectives of this study were to evaluate: - The relative bioavailability of a bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) fixed-dose combination (FDC) pediatric tablet for oral suspension formulation relative to the adult B/F/TAF FDC tablet formulation - The bioequivalence of a emtricitabine/tenofovir alafenamide (F/TAF) FDC pediatric tablet for oral suspension formulation relative to the B/F/TAF FDC pediatric tablet for oral suspension formulation - The relative bioavailability of F/TAF FDC pediatric tablet for oral suspension formulations relative to the adult F/TAF FDC tablet formulation

Protection of trial subjects

The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Jul 2019

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United States: 248

Worldwide total number of subjects

248

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

248

From 65 to 84 years

85 years and over

Subject disposition

Top of page

Recruitment details

Participants were enrolled at study sites in the United States.

Screening details

539 participants were screened.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort 1: Treatment Sequence ABC

Arm description

Participants received treatment A (a single dose of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) 50/200/25 mg adult tablet (1 × 50/200/25 mg tablet) orally under fasted condition) on Day 1, followed by treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted condition) on Day 10 and then treatment C (a single dose of emtricitabine/tenofovir alafenamide (F/TAF) 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

B/F/TAF 50/200/25 mg

Investigational medicinal product code

Other name

Biktarvy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Administered as a single dose

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 50/6.25 mg tablets for oral suspension formulation administered as a single dose

Cohort 1: Treatment Sequence ACB

Arm description

Participants received treatment A (a single dose of B/F/TAF 50/200/25 mg adult tablet (1 × 50/200/25 mg tablet) orally under fasted condition) on Day 1, followed by treatment C (a single dose of F/TAF 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Day 10 and then treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted condition) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

B/F/TAF 50/200/25 mg

Investigational medicinal product code

Other name

Biktarvy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Administered as a single dose

Investigational medicinal product name

F/TAF 50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 50/6.25 mg tablets for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose

Cohort 1: Treatment Sequence BAC

Arm description

Participants received treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted condition) on Day 1, followed by treatmnent A (a single dose of B/F/TAF 50/200/25 mg adult tablet (1 × 50/200/25 mg tablet) orally under fasted condition) on Day 10 and then treatment C (a single dose of F/TAF 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 50/200/25 mg

Investigational medicinal product code

Other name

Biktarvy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Administered as a single dose

Investigational medicinal product name

F/TAF 50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 50/6.25 mg tablets for oral suspension formulation administered as a single dose

Cohort 1: Treatment Sequence BCA

Arm description

Participants received treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted condition) on Day 1, followed by treatment C (a single dose of F/TAF 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Day 10 and then treatment A (a single dose of B/F/TAF 50/200/25 mg adult tablet (1 × 50/200/25 mg tablet) orally under fasted condition) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 50/6.25 mg tablets for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 50/200/25 mg

Investigational medicinal product code

Other name

Biktarvy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Administered as a single dose

Cohort 1: Treatment Sequence CAB

Arm description

Participants received treatment C (a single dose of F/TAF 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Day 1, followed by treatment A (a single dose of B/F/TAF 50/200/25 mg adult tablet (1 × 50/200/25 mg tablet) orally under fasted condition) on Day 10 and then treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted condition) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 50/6.25 mg tablets for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 50/200/25 mg

Investigational medicinal product code

Other name

Biktarvy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Administered as a single dose

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose

Cohort 1: Treatment Sequence CBA

Arm description

Participants received treatment C (a single dose of F/TAF 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Day 1 followed by treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted condition) on Day 10, and then treatment A (a single dose of B/F/TAF 50/200/25 mg adult tablet (1 × 50/200/25 mg tablet) orally under fasted condition) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 50/6.25 mg tablets for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 50/200/25 mg

Investigational medicinal product code

Other name

Biktarvy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

Administered as a single dose

Cohort 2: Treatment Sequence BD

Arm description

Participants received treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted conditions) on Day 1 and then treatment D (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fed conditions) on Day 12. There was a 10-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose under fasted conditions

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose under fed conditions

Cohort 2: Treatment Sequence DB

Arm description

Participants received treatment D (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fed conditions) on Day 1 and then treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted conditions) on Day 12. There was a 10-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose under fed conditions

Investigational medicinal product name

B/F/TAF 12.5/50/6.25 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

4 × 12.5/50/6.25 mg tablets for oral suspension formulation administered as a single dose under fasted conditions

Cohort 3: Treatment Sequence EFG

Arm description

Participants received treatment E (a single dose of B/F/TAF 15/60/7.5 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 1, followed by treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 10 and then Treatment G (a single dose of F/TAF 60/11 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

B/F/TAF 15/60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

15/60/7.5 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/11 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/11 mg tablet for oral suspension formulation administered as a single dose

Cohort 3: Treatment Sequence EGF

Arm description

Participants received treatment E (a single dose of B/F/TAF 15/60/7.5 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 1, followed by treatment G (a single dose of F/TAF 60/11 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 10 and then treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

B/F/TAF 15/60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

15/60/7.5 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/11 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/11 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Cohort 3: Treatment Sequence FEG

Arm description

Participants received treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 1, followed by treatment E (a single dose of B/F/TAF 15/60/7.5 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 10 and then treatment G (a single dose of F/TAF 60/11 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 15/60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

15/60/7.5 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/11 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/11 mg tablet for oral suspension formulation administered as a single dose

Cohort 3: Treatment Sequence FGE

Arm description

Participants received treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 1, followed by treatment G (a single dose of F/TAF 60/11 mg pediatric tablet for oral suspension formulation orally under fasted conditions) on Day 10 and then treatment E (a single dose of B/F/TAF 15/60/7.5 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/11 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/11 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 15/60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

15/60/7.5 mg tablet for oral suspension formulation administered as a single dose

Cohort 3: Treatment Sequence GEF

Arm description

Participants received treatment G (a single dose of F/TAF 60/11 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 1, followed by treatment E (a single dose of B/F/TAF 15/60/7.5 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 10 and then treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/11 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/11 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 15/60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

15/60/7.5 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Cohort 3: Treatment Sequence GFE

Arm description

Participants received treatment G (a single dose of F/TAF 60/11 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 1, followed by treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension formulation orally under fasted conditions) on Day 10 and then treatment E (a single dose of B/F/TAF 15/60/7.5 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/11 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/11 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

B/F/TAF 15/60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

15/60/7.5 mg tablet for oral suspension formulation administered as a single dose

Cohort 4: Treatment Sequence FHI

Arm description

Participants received treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 1, followed by treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Day 10 and the treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 200/25 mg

Investigational medicinal product code

Other name

Descovy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

200/25 mg tablet administered as a single dose

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose

Cohort 4: Treatment Sequence FIH

Arm description

Participants received treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 1, followed by treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Day 10 and then treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment..

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 200/25 mg

Investigational medicinal product code

Other name

Descovy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

200/25 mg tablet administered as a single dose

Cohort 4: Treatment Sequence HFI

Arm description

Participants received treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Day 1, followed by treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 10 and then treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 200/25 mg

Investigational medicinal product code

Other name

Descovy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

200/25 mg tablet administered as a single dose

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose

Cohort 4: Treatment Sequence HIF

Arm description

Participants received treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Day 1, followed by treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Day 10 and then treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 200/25 mg

Investigational medicinal product code

Other name

Descovy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

200/25 mg tablet administered as a single dose

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Cohort 4: Treatment Sequence IFH

Arm description

Participants received treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Day 1, followed by treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 10 and then treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 200/25 mg

Investigational medicinal product code

Other name

Descovy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

200/25 mg tablet administered as a single dose

Cohort 4: Treatment Sequence IHF

Arm description

Participants received treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Day 1, followed by treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Day 10 and then treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose

Investigational medicinal product name

F/TAF 200/25 mg

Investigational medicinal product code

Other name

Descovy®

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

200/25 mg tablet administered as a single dose

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose

Cohort 5: Treatment Sequence JK

Arm description

Participants received treatment J [a single dose of F/TAF (60/10 mg or 60/7.5 mg) pediatric tablet for oral suspension (1 × 60/10 mg or 1 × 60/7.5mg tablet) orally under fasted conditions] on Day 1 and then treatment K [a single dose of F/TAF (60/10 mg or 60/7.5 mg) pediatric tablet for oral single dose pension (1 × 60/10 mg or 1 × 60/7.5mg tablet) orally under fed conditions] on Day 13. There was a 6-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose under fed conditions

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose under fasted conditions

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose under fasted conditions

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose under fed conditions

Cohort 5: Treatment Sequence KJ

Arm description

Participants received treatment K [a single dose of F/TAF (60/10 mg or 60/7.5mg) pediatric tablet for oral suspension (1 × 60/10 mg or 1 × 60/7.5mg tablet) orally under fed conditions] on Day 1 and then treatment J [a single dose of F/TAF (60/10 mg or 60/7.5mg) pediatric tablet for oral suspension (1 × 60/10 mg or 1 × 60/7.5mg tablet) orally under fasted conditions] on Day 13. There was a 6-day washout between each treatment.

Arm type

Experimental

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose under fasted conditions

Investigational medicinal product name

F/TAF 60/10 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/10 mg tablet for oral suspension formulation administered as a single dose under fed conditions

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose under fed conditions

Investigational medicinal product name

F/TAF 60/7.5 mg

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

60/7.5 mg tablet for oral suspension formulation administered as a single dose under fasted conditions

Number of subjects in period 1	Cohort 1: Treatment Sequence ABC	Cohort 1: Treatment Sequence ACB	Cohort 1: Treatment Sequence BAC	Cohort 1: Treatment Sequence BCA	Cohort 1: Treatment Sequence CAB	Cohort 1: Treatment Sequence CBA	Cohort 2: Treatment Sequence BD	Cohort 2: Treatment Sequence DB	Cohort 3: Treatment Sequence EFG	Cohort 3: Treatment Sequence EGF	Cohort 3: Treatment Sequence FEG	Cohort 3: Treatment Sequence FGE	Cohort 3: Treatment Sequence GEF	Cohort 3: Treatment Sequence GFE	Cohort 4: Treatment Sequence FHI	Cohort 4: Treatment Sequence FIH	Cohort 4: Treatment Sequence HFI	Cohort 4: Treatment Sequence HIF	Cohort 4: Treatment Sequence IFH	Cohort 4: Treatment Sequence IHF	Cohort 5: Treatment Sequence JK	Cohort 5: Treatment Sequence KJ
Started	16	16	16	16	16	16	18	18	11	11	11	11	11	11	5	5	5	5	5	5	10	10
Completed	16	16	16	16	16	16	18	18	10	11	10	11	11	11	5	5	5	5	4	5	10	10
Not completed	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	1	0	0	0
Protocol violation	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-
Withdrew consent	-	-	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	1	-	-	-

Baseline characteristics

Top of page

Reporting group title

Cohort 1: Treatment Sequence ABC

Reporting group description

Reporting group title

Cohort 1: Treatment Sequence ACB

Reporting group description

Reporting group title

Cohort 1: Treatment Sequence BAC

Reporting group description

Reporting group title

Cohort 1: Treatment Sequence BCA

Reporting group description

Participants received treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted condition) on Day 1, followed by treatment C (a single dose of F/TAF 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Day 10 and then treatment A (a single dose of B/F/TAF 50/200/25 mg adult tablet (1 × 50/200/25 mg tablet) orally under fasted condition) on Day 19. There was a 8-day washout between each treatment.

Reporting group title

Cohort 1: Treatment Sequence CAB

Reporting group description

Reporting group title

Cohort 1: Treatment Sequence CBA

Reporting group description

Reporting group title

Cohort 2: Treatment Sequence BD

Reporting group description

Reporting group title

Cohort 2: Treatment Sequence DB

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence EFG

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence EGF

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence FEG

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence FGE

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence GEF

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence GFE

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence FHI

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence FIH

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence HFI

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence HIF

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence IFH

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence IHF

Reporting group description

Participants received treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Day 1, followed by treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Day 10 and then treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Reporting group title

Cohort 5: Treatment Sequence JK

Reporting group description

Reporting group title

Cohort 5: Treatment Sequence KJ

Reporting group description

Reporting group values	Cohort 1: Treatment Sequence ABC	Cohort 1: Treatment Sequence ACB	Cohort 1: Treatment Sequence BAC	Cohort 1: Treatment Sequence BCA	Cohort 1: Treatment Sequence CAB	Cohort 1: Treatment Sequence CBA	Cohort 2: Treatment Sequence BD	Cohort 2: Treatment Sequence DB	Cohort 3: Treatment Sequence EFG	Cohort 3: Treatment Sequence EGF	Cohort 3: Treatment Sequence FEG	Cohort 3: Treatment Sequence FGE	Cohort 3: Treatment Sequence GEF	Cohort 3: Treatment Sequence GFE	Cohort 4: Treatment Sequence FHI	Cohort 4: Treatment Sequence FIH	Cohort 4: Treatment Sequence HFI	Cohort 4: Treatment Sequence HIF	Cohort 4: Treatment Sequence IFH	Cohort 4: Treatment Sequence IHF	Cohort 5: Treatment Sequence JK	Cohort 5: Treatment Sequence KJ	Total
Number of subjects	16	16	16	16	16	16	18	18	11	11	11	11	11	11	5	5	5	5	5	5	10	10	248
Age categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	34 ( 4.7 )	28 ( 5.7 )	34 ( 7.1 )	37 ( 4.6 )	33 ( 6.6 )	33 ( 7.7 )	32 ( 7.1 )	33 ( 7.2 )	32 ( 5.6 )	29 ( 6.5 )	33 ( 6.7 )	33 ( 5.2 )	28 ( 7.4 )	37 ( 5.8 )	32 ( 9.3 )	37 ( 1.1 )	38 ( 5.3 )	35 ( 6.3 )	32 ( 4.8 )	33 ( 5.9 )	36 ( 7.8 )	36 ( 6.4 )	-
Gender categorical
Units: Subjects
Female	5	6	5	4	8	7	11	6	5	5	1	3	2	5	2	3	2	4	2	2	4	4	96
Male	11	10	11	12	8	9	7	12	6	6	10	8	9	6	3	2	3	1	3	3	6	6	152
Race
Units: Subjects
American Indian or Alaska Native	1	2	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	5
Asian	1	0	0	0	0	0	0	0	0	0	2	0	1	0	0	0	0	0	0	0	0	0	4
Black	7	10	6	7	10	11	7	9	5	5	3	4	3	5	0	0	3	1	1	0	4	1	102
Native Hawaiian or Pacific Islander	0	0	0	0	1	0	2	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	4
White	7	4	8	9	5	5	9	7	6	4	6	6	6	6	5	5	2	4	4	5	6	9	128
Other	0	0	2	0	0	0	0	2	0	1	0	0	0	0	0	0	0	0	0	0	0	0	5
Ethnicity
Units: Subjects
Hispanic or Latino	7	3	6	4	4	4	9	7	4	3	4	4	5	3	5	5	5	5	5	5	10	9	116
Not Hispanic or Latino	9	13	10	12	12	12	9	11	7	8	7	7	6	8	0	0	0	0	0	0	0	1	132

End points

Top of page

Reporting group title

Cohort 1: Treatment Sequence ABC

Reporting group description

Reporting group title

Cohort 1: Treatment Sequence ACB

Reporting group description

Reporting group title

Cohort 1: Treatment Sequence BAC

Reporting group description

Reporting group title

Cohort 1: Treatment Sequence BCA

Reporting group description

Participants received treatment B (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fasted condition) on Day 1, followed by treatment C (a single dose of F/TAF 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Day 10 and then treatment A (a single dose of B/F/TAF 50/200/25 mg adult tablet (1 × 50/200/25 mg tablet) orally under fasted condition) on Day 19. There was a 8-day washout between each treatment.

Reporting group title

Cohort 1: Treatment Sequence CAB

Reporting group description

Reporting group title

Cohort 1: Treatment Sequence CBA

Reporting group description

Reporting group title

Cohort 2: Treatment Sequence BD

Reporting group description

Reporting group title

Cohort 2: Treatment Sequence DB

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence EFG

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence EGF

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence FEG

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence FGE

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence GEF

Reporting group description

Reporting group title

Cohort 3: Treatment Sequence GFE

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence FHI

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence FIH

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence HFI

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence HIF

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence IFH

Reporting group description

Reporting group title

Cohort 4: Treatment Sequence IHF

Reporting group description

Participants received treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Day 1, followed by treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Day 10 and then treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Day 19. There was a 8-day washout between each treatment.

Reporting group title

Cohort 5: Treatment Sequence JK

Reporting group description

Reporting group title

Cohort 5: Treatment Sequence KJ

Reporting group description

Subject analysis set title

Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment A (a single of B/F/TAF 50/200/25 mg adult tablet (1× 50/200/25 mg tablet) orally under fasted condition) on Days 1, 10, or 19 according to the treatment sequence for Cohort 1.

Subject analysis set title

Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment C (a single dose of F/TAF 200/25 mg pediatric tablet for oral suspension (4 × 50/6.25 mg tablet) orally under fasted condition) on Days 1, 10, or 19 according to the treatment sequence for Cohort 1.

Subject analysis set title

Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment D (a single dose of B/F/TAF 50/200/25 mg pediatric tablet for oral suspension (4 × 12.5/50/6.25 mg tablet) orally under fed conditions) on Days 1, or 12 according to the treatment sequence for Cohort 2.

Subject analysis set title

Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment F (a single dose of B/F/TAF 15/60/7.5 mg pediatric tablet for oral suspension orally under fasted conditions) on Days 1, 10, or 19 according to the treatment sequence for Cohort 3.

Subject analysis set title

Cohort 3 F (F/TAF 60/10 mg pediatric tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment F (a single dose of F/TAF 60/10 mg pediatric tablet for oral suspension orally under fasted conditions) on Days 1, 10, or 19 according to the treatment sequence for Cohort 3.

Subject analysis set title

Cohort 3 G (F/TAF 60/11 mg pediatric tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment G (a single dose of F/TAF 60/11 mg pediatric tablet for oral suspension orally under fasted conditions) on Days 1, 10, or 19 according to the treatment sequence for Cohort 3.

Subject analysis set title

Cohort 4 F (F/TAF 60/10 mg pediatric tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

Cohort 4 H (F/TAF 200/25 mg adult tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment H (a single dose of F/TAF 200/25 mg adult tablet (1 × 200/25 mg tablet) orally under fasted conditions) on Days 1, 10, or 19 according to the treatment sequence for Cohort 4.

Subject analysis set title

Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment I (a single dose of F/TAF 60/7.5 mg pediatric tablet for oral suspension (1 × 60/7.5 mg tablet) orally under fasted conditions) on Days 1, 10 , or 19 according to the treatment sequence for Cohort 4.

Subject analysis set title

Cohort 5 J (F/TAF 60/10 mg pediatric tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment J (a single dose of F/TAF (60/10 mg) pediatric tablet for oral suspension (1 × 60/10 mg tablet) orally under fasted conditions) on Days 1 or 13 according to the treatment sequence for Cohort 5.

Subject analysis set title

Cohort 5 K (F/TAF 60/10 mg pediatric tablet)

Subject analysis set type

Full analysis

Subject analysis set description

Participants received treatment K (a single dose of F/TAF (60/10 mg ) pediatric tablet for oral suspension (1 × 60/10 mg tablet) orally under fed conditions) on Days 1, or 13 according to the treatment sequence for Cohort 5.

Primary: Cohorts 1 and 3: Pharmacokinetic (PK) Parameter of Bictegravir (BIC): Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)

Top of page

End point title

Cohorts 1 and 3: Pharmacokinetic (PK) Parameter of Bictegravir (BIC): Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) ^[1]

End point description

PK analysis set included all randomized participants who took at least 1 dose of study drug and had at least 1 non-missing post dose concentration value reported by the PK laboratory for the corresponding analyte.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	66
Units: hoursnanograms per milliliter (hng/mL)
arithmetic mean (standard deviation)	109596.7 ( 28725.05 )	131863.9 ( 28769.05 )	37472.7 ( 6921.35 )

No statistical analyses for this end point

Primary: Cohorts 1 and 3: PK Parameter of BIC: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUCinf)

Top of page

End point title

Cohorts 1 and 3: PK Parameter of BIC: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUCinf) ^[2]

End point description

Participants in the PK Analysis Set were analyzed.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	66
Units: h*ng/mL
arithmetic mean (standard deviation)	111101.0 ( 29305.00 )	133655.1 ( 29773.87 )	38684.8 ( 7403.16 )

No statistical analyses for this end point

Primary: Cohorts 1 and 3: PK Parameter of BIC: Maximum Observed Plasma Concentration of Drug (Cmax)

Top of page

End point title

Cohorts 1 and 3: PK Parameter of BIC: Maximum Observed Plasma Concentration of Drug (Cmax) ^[3]

End point description

Participants in the PK Analysis Set were analyzed.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	66
Units: nanograms per milliliter (ng/mL)
arithmetic mean (standard deviation)	5607.5 ( 1275.94 )	8230.1 ( 1444.72 )	2443.6 ( 420.41 )

No statistical analyses for this end point

Primary: Cohorts 1, 3 and 4: PK Parameter of Emtricitabine (FTC): AUClast

Top of page

End point title

Cohorts 1, 3 and 4: PK Parameter of Emtricitabine (FTC): AUClast ^[4]

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)	Cohort 3 F (F/TAF 60/10 mg pediatric tablet)	Cohort 3 G (F/TAF 60/11 mg pediatric tablet)	Cohort 4 F (F/TAF 60/10 mg pediatric tablet)	Cohort 4 H (F/TAF 200/25 mg adult tablet)	Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	96	66	65	64	29	29	30
Units: h*ng/mL
arithmetic mean (standard deviation)	11504.4 ( 1787.45 )	10674.8 ( 2181.88 )	10566.6 ( 1688.08 )	3110.0 ( 530.30 )	3144.2 ( 596.18 )	3163.3 ( 530.28 )	2740.3 ( 558.89 )	9946.9 ( 2016.40 )	2734.0 ( 520.08 )

No statistical analyses for this end point

Primary: Cohorts 1, 3 and 4: PK Parameter of FTC: AUCinf

Top of page

End point title

Cohorts 1, 3 and 4: PK Parameter of FTC: AUCinf ^[5]

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)	Cohort 3 F (F/TAF 60/10 mg pediatric tablet)	Cohort 3 G (F/TAF 60/11 mg pediatric tablet)	Cohort 4 F (F/TAF 60/10 mg pediatric tablet)	Cohort 4 H (F/TAF 200/25 mg adult tablet)	Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	96	63	63	59	29	29	29
Units: h*ng/mL
arithmetic mean (standard deviation)	11804.1 ( 1794.57 )	11009.5 ( 2257.20 )	10918.5 ( 1729.34 )	3219.5 ( 541.61 )	3294.1 ( 607.17 )	3304.9 ( 541.68 )	2843.1 ( 563.36 )	10143.8 ( 2041.22 )	2834.5 ( 546.21 )

No statistical analyses for this end point

Primary: Cohorts 1, 3 and 4: PK Parameter of FTC: Cmax

Top of page

End point title

Cohorts 1, 3 and 4: PK Parameter of FTC: Cmax ^[6]

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)	Cohort 3 F (F/TAF 60/10 mg pediatric tablet)	Cohort 3 G (F/TAF 60/11 mg pediatric tablet)	Cohort 4 F (F/TAF 60/10 mg pediatric tablet)	Cohort 4 H (F/TAF 200/25 mg adult tablet)	Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	96	66	65	64	29	29	30
Units: ng/mL
arithmetic mean (standard deviation)	2340.7 ( 644.56 )	1932.8 ( 382.02 )	1895.0 ( 388.20 )	685.4 ( 163.86 )	663.1 ( 168.49 )	671.7 ( 146.60 )	635.2 ( 139.60 )	2268.3 ( 599.63 )	619.1 ( 148.66 )

No statistical analyses for this end point

Primary: Cohorts 1, 3 and 4: PK Parameter of Tenofovir Alafenamide (TAF): AUClast

Top of page

End point title

Cohorts 1, 3 and 4: PK Parameter of Tenofovir Alafenamide (TAF): AUClast ^[7]

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)	Cohort 3 F (F/TAF 60/10 mg pediatric tablet)	Cohort 3 G (F/TAF 60/11 mg pediatric tablet)	Cohort 4 F (F/TAF 60/10 mg pediatric tablet)	Cohort 4 H (F/TAF 200/25 mg adult tablet)	Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	96	66	65	64	29	29	30
Units: h*ng/mL
arithmetic mean (standard deviation)	221.1 ( 124.56 )	229.9 ( 130.07 )	161.2 ( 80.93 )	49.0 ( 23.47 )	51.6 ( 23.81 )	56.0 ( 23.65 )	67.7 ( 34.10 )	214.8 ( 133.66 )	51.3 ( 28.43 )

No statistical analyses for this end point

Primary: Cohorts 1, 3 and 4: PK Parameter of TAF: AUCinf

Top of page

End point title

Cohorts 1, 3 and 4: PK Parameter of TAF: AUCinf ^[8]

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)	Cohort 3 F (F/TAF 60/10 mg pediatric tablet)	Cohort 3 G (F/TAF 60/11 mg pediatric tablet)	Cohort 4 F (F/TAF 60/10 mg pediatric tablet)	Cohort 4 H (F/TAF 200/25 mg adult tablet)	Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	96	66	65	63	29	28	30
Units: h*ng/mL
arithmetic mean (standard deviation)	222.6 ( 124.62 )	231.3 ( 130.11 )	162.7 ( 80.89 )	50.1 ( 23.64 )	52.8 ( 24.22 )	57.4 ( 23.78 )	68.8 ( 34.33 )	215.8 ( 136.03 )	52.9 ( 28.49 )

No statistical analyses for this end point

Primary: Cohorts 1, 3 and 4: PK Parameter of TAF: Cmax

Top of page

End point title

Cohorts 1, 3 and 4: PK Parameter of TAF: Cmax ^[9]

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Primary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1, 10, or 19

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No statistical comparison was planned or performed.

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)	Cohort 3 F (F/TAF 60/10 mg pediatric tablet)	Cohort 3 G (F/TAF 60/11 mg pediatric tablet)	Cohort 4 F (F/TAF 60/10 mg pediatric tablet)	Cohort 4 H (F/TAF 200/25 mg adult tablet)	Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)
Number of subjects analysed	96	96	96	66	65	64	29	29	30
Units: ng/mL
arithmetic mean (standard deviation)	325.9 ( 205.18 )	341.9 ( 153.36 )	233.2 ( 111.77 )	85.7 ( 35.15 )	79.1 ( 32.25 )	90.1 ( 35.79 )	116.1 ( 60.75 )	333.1 ( 210.10 )	79.7 ( 39.55 )

No statistical analyses for this end point

Secondary: Cohort 2: PK Parameter of BIC: AUClast

Top of page

End point title

Cohort 2: PK Parameter of BIC: AUClast

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: h*ng/mL
arithmetic mean (standard deviation)	128870.5 ( 29350.20 )	120261.5 ( 28446.78 )

No statistical analyses for this end point

Secondary: Cohort 2: PK Parameter of BIC: AUCinf

Top of page

End point title

Cohort 2: PK Parameter of BIC: AUCinf

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: h*ng/mL
arithmetic mean (standard deviation)	130472.1 ( 30598.63 )	121724.3 ( 29263.42 )

No statistical analyses for this end point

Secondary: Cohort 2: PK Parameter of BIC: Cmax

Top of page

End point title

Cohort 2: PK Parameter of BIC: Cmax

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: ng/mL
arithmetic mean (standard deviation)	8345.6 ( 1303.45 )	4889.1 ( 851.69 )

No statistical analyses for this end point

Secondary: Cohort 2: PK Parameter of FTC: AUClast

Top of page

End point title

Cohort 2: PK Parameter of FTC: AUClast

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: h*ng/mL
arithmetic mean (standard deviation)	10369.5 ( 1882.89 )	10197.5 ( 1796.43 )

No statistical analyses for this end point

Secondary: Cohorts 2 : PK Parameter of FTC: AUCinf

Top of page

End point title

Cohorts 2 : PK Parameter of FTC: AUCinf

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 and 12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: h*ng/mL
arithmetic mean (standard deviation)	10698.1 ( 1902.11 )	10490.3 ( 1780.50 )

No statistical analyses for this end point

Secondary: Cohorts 2 : PK Parameter of FTC: Cmax

Top of page

End point title

Cohorts 2 : PK Parameter of FTC: Cmax

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: ng/mL
arithmetic mean (standard deviation)	1996.7 ( 450.23 )	1384.7 ( 336.01 )

No statistical analyses for this end point

Secondary: Cohort 2: PK Parameter of TAF: AUClast

Top of page

End point title

Cohort 2: PK Parameter of TAF: AUClast

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: h*ng/mL
arithmetic mean (standard deviation)	205.2 ( 79.19 )	244.5 ( 85.10 )

No statistical analyses for this end point

Secondary: Cohort 2 : PK Parameter of TAF: AUCinf

Top of page

End point title

Cohort 2 : PK Parameter of TAF: AUCinf

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: h*ng/mL
arithmetic mean (standard deviation)	206.6 ( 79.30 )	248.9 ( 84.28 )

No statistical analyses for this end point

Secondary: Cohort 2 : PK Parameter of TAF: Cmax

Top of page

End point title

Cohort 2 : PK Parameter of TAF: Cmax

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 12

End point values	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)
Number of subjects analysed	36	35
Units: ng/mL
arithmetic mean (standard deviation)	365.7 ( 131.98 )	153.7 ( 88.75 )

No statistical analyses for this end point

Secondary: Cohort 5: PK Parameter of FTC: AUClast

Top of page

End point title

Cohort 5: PK Parameter of FTC: AUClast

End point description

Participants in the PK Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 8

End point values	Cohort 5 J (F/TAF 60/10 mg pediatric tablet)	Cohort 5 K (F/TAF 60/10 mg pediatric tablet)
Number of subjects analysed	20	20
Units: h*ng/mL
arithmetic mean (standard deviation)	2689.5 ( 408.26 )	2595.0 ( 366.73 )

No statistical analyses for this end point

Secondary: Cohorts 5: PK Parameter of FTC: AUCinf

Top of page

End point title

Cohorts 5: PK Parameter of FTC: AUCinf

End point description

Participants in the PK Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 8

End point values	Cohort 5 J (F/TAF 60/10 mg pediatric tablet)	Cohort 5 K (F/TAF 60/10 mg pediatric tablet)
Number of subjects analysed	18	20
Units: h*ng/mL
arithmetic mean (standard deviation)	2792.8 ( 437.50 )	2718.0 ( 386.90 )

No statistical analyses for this end point

Secondary: Cohort 5: PK Parameter of FTC: Cmax

Top of page

End point title

Cohort 5: PK Parameter of FTC: Cmax

End point description

Participants in the PK Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 8

End point values	Cohort 5 J (F/TAF 60/10 mg pediatric tablet)	Cohort 5 K (F/TAF 60/10 mg pediatric tablet)
Number of subjects analysed	20	20
Units: ng/mL
arithmetic mean (standard deviation)	588.9 ( 155.98 )	350.1 ( 68.74 )

No statistical analyses for this end point

Secondary: Cohort 5: PK Parameter of TAF: AUClast

Top of page

End point title

Cohort 5: PK Parameter of TAF: AUClast

End point description

Participants in the PK Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 8

End point values	Cohort 5 J (F/TAF 60/10 mg pediatric tablet)	Cohort 5 K (F/TAF 60/10 mg pediatric tablet)
Number of subjects analysed	20	20
Units: h*ng/mL
arithmetic mean (standard deviation)	68.5 ( 24.73 )	104.0 ( 35.85 )

No statistical analyses for this end point

Secondary: Cohort 5: PK Parameter of TAF: AUCinf

Top of page

End point title

Cohort 5: PK Parameter of TAF: AUCinf

End point description

Participants in the PK Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 8

End point values	Cohort 5 J (F/TAF 60/10 mg pediatric tablet)	Cohort 5 K (F/TAF 60/10 mg pediatric tablet)
Number of subjects analysed	20	20
Units: h*ng/mL
arithmetic mean (standard deviation)	69.6 ( 24.94 )	106.4 ( 35.31 )

No statistical analyses for this end point

Secondary: Cohort 5: PK Parameter of TAF: Cmax

Top of page

End point title

Cohort 5: PK Parameter of TAF: Cmax

End point description

Participants in the PK Analysis Set were analyzed.

End point type

Secondary

End point timeframe

Predose (≤ 5 min), 5 min, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96, and 120 hours postdose on Days 1 or 8

End point values	Cohort 5 J (F/TAF 60/10 mg pediatric tablet)	Cohort 5 K (F/TAF 60/10 mg pediatric tablet)
Number of subjects analysed	20	20
Units: ng/mL
arithmetic mean (standard deviation)	105.2 ( 49.10 )	50.6 ( 23.51 )

No statistical analyses for this end point

Secondary: Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Top of page

End point title

Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

End point description

TEAEs were defined as 1 or both of any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Safety Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants in the Safety Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

First dose date up to 3 days plus 30 days

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)	Cohort 3 F (F/TAF 60/10 mg pediatric tablet)	Cohort 3 G (F/TAF 60/11 mg pediatric tablet)	Cohort 4 F (F/TAF 60/10 mg pediatric tablet)	Cohort 4 H (F/TAF 200/25 mg adult tablet)	Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)	Cohort 5 J (F/TAF 60/10 mg pediatric tablet)	Cohort 5 K (F/TAF 60/10 mg pediatric tablet)
Number of subjects analysed	96	96	96	36	36	66	65	64	29	29	30	20	20
Units: percentage of participants
number (not applicable)	10.4	10.4	18.8	11.1	2.8	9.1	16.9	9.4	10.3	10.3	6.7	5.0	5.0

No statistical analyses for this end point

Secondary: Percentage of Participants Who Experienced Laboratory Abnormalities

Top of page

End point title

Percentage of Participants Who Experienced Laboratory Abnormalities

End point description

Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from the predose assessment associated with a treatment and occurring after the first dose of that treatment and on or before the date of the last dose of that treatment plus 30 days or before the first dose of the following treatment (if applicable), whichever occurs earlier. If the relevant predose laboratory value is missing, any abnormality of at least Grade 1 observed within the time frame specified above will be considered treatment emergent. Participants in the Safety Analysis Set with available data were analyzed.

End point type

Secondary

End point timeframe

First dose date up to 3 days plus 30 days

End point values	Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet)	Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets)	Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets)	Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet)	Cohort 3 F (F/TAF 60/10 mg pediatric tablet)	Cohort 3 G (F/TAF 60/11 mg pediatric tablet)	Cohort 4 F (F/TAF 60/10 mg pediatric tablet)	Cohort 4 H (F/TAF 200/25 mg adult tablet)	Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet)	Cohort 5 J (F/TAF 60/10 mg pediatric tablet)	Cohort 5 K (F/TAF 60/10 mg pediatric tablet)
Number of subjects analysed	96	96	96	36	36	66	66	66	29	29	30	20	20
Units: percentage of participants
number (not applicable)
Grade 1	19.8	17.7	14.6	13.9	19.4	19.7	20.0	20.3	37.9	24.1	26.7	30.0	25.0
Grade 2	3.1	3.1	3.1	2.8	2.8	1.5	7.7	3.1	10.3	6.9	13.3	10.0	5.0
Grade 3	5.2	3.1	1.0	5.6	5.6	3.0	3.1	1.6	6.9	3.4	0	5.0	0
Grade 4	0	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

All-cause mortality: Enrollment up to 58 days Adverse events: First dose date up to 3 days plus 30 days

Adverse event reporting additional description

All-cause mortality: All Randomized Analysis Set included all participants randomized into the study after screening. Adverse events: Safety Analysis Set included all randomized participants who took at least 1 dose of study drug.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.1

Reporting group title

Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet )

Reporting group description

Reporting group title

Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Reporting group description

Reporting group title

Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets )

Reporting group description

Reporting group title

Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Reporting group description

Reporting group title

Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Reporting group description

Reporting group title

Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet )

Reporting group description

Reporting group title

Cohort 3 F (F/TAF 60/10 mg pediatric tablet )

Reporting group description

Reporting group title

Cohort 3 G (F/TAF 60/11 mg pediatric tablet )

Reporting group description

Reporting group title

Cohort 4 F (F/TAF 60/10 mg pediatric tablet )

Reporting group description

Reporting group title

Cohort 4 H (F/TAF 200/25 mg adult tablet )

Reporting group description

Reporting group title

Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet )

Reporting group description

Reporting group title

Cohort 5 J (F/TAF 60/10 mg pediatric tablet )

Reporting group description

Reporting group title

Cohort 5 K (F/TAF 60/10 mg pediatric tablet )

Reporting group description

Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet )

Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets )

Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet )

Cohort 3 F (F/TAF 60/10 mg pediatric tablet )

Cohort 3 G (F/TAF 60/11 mg pediatric tablet )

Cohort 4 F (F/TAF 60/10 mg pediatric tablet )

Cohort 4 H (F/TAF 200/25 mg adult tablet )

Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet )

Cohort 5 J (F/TAF 60/10 mg pediatric tablet )

Cohort 5 K (F/TAF 60/10 mg pediatric tablet )

Total subjects affected by serious adverse events

subjects affected / exposed

0 / 96 (0.00%)

0 / 36 (0.00%)

0 / 66 (0.00%)

0 / 65 (0.00%)

0 / 64 (0.00%)

1 / 29 (3.45%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 20 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Infections and infestations

Appendicitis

subjects affected / exposed

0 / 96 (0.00%)

0 / 36 (0.00%)

0 / 66 (0.00%)

0 / 65 (0.00%)

0 / 64 (0.00%)

1 / 29 (3.45%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 20 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Cohort 1 A (B/F/TAF 50/200/25 mg adult tablet )

Cohort 1 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Cohort 1 C (F/TAF 4 * 50/6.25 mg pediatric tablets )

Cohort 2 B (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Cohort 2 D (B/F/TAF 4 * 12.5/50/6.25 mg pediatric tablets )

Cohort 3 E (B/F/TAF 15/60/7.5 mg pediatric tablet )

Cohort 3 F (F/TAF 60/10 mg pediatric tablet )

Cohort 3 G (F/TAF 60/11 mg pediatric tablet )

Cohort 4 F (F/TAF 60/10 mg pediatric tablet )

Cohort 4 H (F/TAF 200/25 mg adult tablet )

Cohort 4 I (F/TAF 60/7.5 mg pediatric tablet )

Cohort 5 J (F/TAF 60/10 mg pediatric tablet )

Cohort 5 K (F/TAF 60/10 mg pediatric tablet )

Total subjects affected by non serious adverse events

subjects affected / exposed

3 / 96 (3.13%)

4 / 96 (4.17%)

7 / 96 (7.29%)

1 / 36 (2.78%)

0 / 36 (0.00%)

3 / 66 (4.55%)

4 / 65 (6.15%)

3 / 64 (4.69%)

2 / 29 (6.90%)

1 / 29 (3.45%)

2 / 30 (6.67%)

1 / 20 (5.00%)

Nervous system disorders

Headache

subjects affected / exposed

2 / 96 (2.08%)

3 / 96 (3.13%)

1 / 36 (2.78%)

0 / 36 (0.00%)

3 / 66 (4.55%)

2 / 65 (3.08%)

2 / 64 (3.13%)

1 / 29 (3.45%)

2 / 30 (6.67%)

0 / 20 (0.00%)

occurrences all number

Gastrointestinal disorders

Nausea

subjects affected / exposed

3 / 96 (3.13%)

5 / 96 (5.21%)

1 / 36 (2.78%)

0 / 36 (0.00%)

0 / 66 (0.00%)

1 / 65 (1.54%)

1 / 64 (1.56%)

1 / 29 (3.45%)

0 / 29 (0.00%)

0 / 30 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

occurrences all number

Respiratory, thoracic and mediastinal disorders

Nasal congestion

subjects affected / exposed

0 / 96 (0.00%)

0 / 36 (0.00%)

0 / 66 (0.00%)

1 / 65 (1.54%)

0 / 64 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

occurrences all number

Oropharyngeal pain

subjects affected / exposed

0 / 96 (0.00%)

0 / 36 (0.00%)

0 / 66 (0.00%)

0 / 65 (0.00%)

0 / 64 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

occurrences all number

Psychiatric disorders

Anxiety

subjects affected / exposed

0 / 96 (0.00%)

0 / 36 (0.00%)

0 / 66 (0.00%)

0 / 65 (0.00%)

0 / 64 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

occurrences all number

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

10 Jun 2020

- Addition of Cohort 3 to evaluate B/F/TAF and F/TAF fixed dose combination (FDC) pediatric tablets for oral suspension formulations containing alternative ratios of emtricitabine and tenofovir alafenamide - Updated to provide the description of formulations for alternative ratios of B/F/TAF and F/TAF FDC pediatric tablets for oral suspension

12 May 2021

- Addition of Cohort 4 to evaluate the relative bioavailability of F/TAF FDC pediatric tablet for oral suspension formulations relative to the adult F/TAF FDC tablet formulation - Addition of Cohort 5 to evaluate the effect of concomitant food intake on the PK of a F/TAF FDC pediatric tablet for oral suspension formulation

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: A Phase 1, Single-Dose, Cross-Over Study Evaluating the Relative Bioavailability and Food Effect of the Bictegravir/Emtricitabine/Tenofovir Alafenamide and Emtricitabine/Tenofovir Alafenamide Pediatric Tablets for Oral Suspension as Compared with the Adult-Strength Tablets

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Cohorts 1 and 3: Pharmacokinetic (PK) Parameter of Bictegravir (BIC): Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)

Primary: Cohorts 1 and 3: Pharmacokinetic (PK) Parameter of Bictegravir (BIC): Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)

Primary: Cohorts 1 and 3: PK Parameter of BIC: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUCinf)

Primary: Cohorts 1 and 3: PK Parameter of BIC: Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUCinf)

Primary: Cohorts 1 and 3: PK Parameter of BIC: Maximum Observed Plasma Concentration of Drug (Cmax)

Primary: Cohorts 1 and 3: PK Parameter of BIC: Maximum Observed Plasma Concentration of Drug (Cmax)

Primary: Cohorts 1, 3 and 4: PK Parameter of Emtricitabine (FTC): AUClast

Primary: Cohorts 1, 3 and 4: PK Parameter of Emtricitabine (FTC): AUClast

Primary: Cohorts 1, 3 and 4: PK Parameter of FTC: AUCinf

Primary: Cohorts 1, 3 and 4: PK Parameter of FTC: AUCinf

Primary: Cohorts 1, 3 and 4: PK Parameter of FTC: Cmax

Primary: Cohorts 1, 3 and 4: PK Parameter of FTC: Cmax

Primary: Cohorts 1, 3 and 4: PK Parameter of Tenofovir Alafenamide (TAF): AUClast

Primary: Cohorts 1, 3 and 4: PK Parameter of Tenofovir Alafenamide (TAF): AUClast

Primary: Cohorts 1, 3 and 4: PK Parameter of TAF: AUCinf

Primary: Cohorts 1, 3 and 4: PK Parameter of TAF: AUCinf

Primary: Cohorts 1, 3 and 4: PK Parameter of TAF: Cmax

Primary: Cohorts 1, 3 and 4: PK Parameter of TAF: Cmax

Secondary: Cohort 2: PK Parameter of BIC: AUClast

Secondary: Cohort 2: PK Parameter of BIC: AUClast

Secondary: Cohort 2: PK Parameter of BIC: AUCinf

Secondary: Cohort 2: PK Parameter of BIC: AUCinf

Secondary: Cohort 2: PK Parameter of BIC: Cmax

Secondary: Cohort 2: PK Parameter of BIC: Cmax

Secondary: Cohort 2: PK Parameter of FTC: AUClast

Secondary: Cohort 2: PK Parameter of FTC: AUClast

Secondary: Cohorts 2 : PK Parameter of FTC: AUCinf

Secondary: Cohorts 2 : PK Parameter of FTC: AUCinf

Secondary: Cohorts 2 : PK Parameter of FTC: Cmax

Secondary: Cohorts 2 : PK Parameter of FTC: Cmax

Secondary: Cohort 2: PK Parameter of TAF: AUClast

Secondary: Cohort 2: PK Parameter of TAF: AUClast

Secondary: Cohort 2 : PK Parameter of TAF: AUCinf

Secondary: Cohort 2 : PK Parameter of TAF: AUCinf

Secondary: Cohort 2 : PK Parameter of TAF: Cmax

Secondary: Cohort 2 : PK Parameter of TAF: Cmax

Secondary: Cohort 5: PK Parameter of FTC: AUClast

Secondary: Cohort 5: PK Parameter of FTC: AUClast

Secondary: Cohorts 5: PK Parameter of FTC: AUCinf

Secondary: Cohorts 5: PK Parameter of FTC: AUCinf

Secondary: Cohort 5: PK Parameter of FTC: Cmax

Secondary: Cohort 5: PK Parameter of FTC: Cmax

Secondary: Cohort 5: PK Parameter of TAF: AUClast

Secondary: Cohort 5: PK Parameter of TAF: AUClast

Secondary: Cohort 5: PK Parameter of TAF: AUCinf

Secondary: Cohort 5: PK Parameter of TAF: AUCinf

Secondary: Cohort 5: PK Parameter of TAF: Cmax

Secondary: Cohort 5: PK Parameter of TAF: Cmax

Secondary: Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Secondary: Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)

Secondary: Percentage of Participants Who Experienced Laboratory Abnormalities

Secondary: Percentage of Participants Who Experienced Laboratory Abnormalities

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 1, Single-Dose, Cross-Over Study Evaluating the Relative Bioavailability and Food Effect of the Bictegravir/Emtricitabine/Tenofovir Alafenamide and Emtricitabine/Tenofovir Alafenamide Pediatric Tablets for Oral Suspension as Compared with the Adult-Strength Tablets