Clinical Trials Register

Summary
EudraCT Number:	2017-004044-37
Sponsor's Protocol Code Number:	GS-US-342-1142
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-12-07
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2017-004044-37

A.3

Full title of the trial

A Phase 1 Relative Bioavailability and Food Effect Study of a Pediatric Oral Granule Formulation of SOF/VEL in Healthy Adult
Subjects.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Bioavailability and food effects of the pediatric formulation of SOF/VEL in adult subjects.

A.4.1

Sponsor's protocol code number

GS-US-342-1142

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/190/2017

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Gilead Sciences, Inc.
B.1.3.4	Country	United States
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Gilead Sciences, Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Gilead Sciences, Inc.
B.5.2	Functional name of contact point	Diana Brainard, MD
B.5.3	Address:
B.5.3.1	Street Address	333 Lakeside Drive
B.5.3.2	Town/ city	Foster City
B.5.3.3	Post code	CA 94404
B.5.3.4	Country	United States
B.5.4	Telephone number	+116505224761
B.5.5	Fax number	+116505221975

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Epclusa 400 mg / 100 mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	Gilead Sciences International Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Epclusa 400 mg/100 mg filmcoated
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sovaldi
D.3.9.1	CAS number	1190307-88-0
D.3.9.2	Current sponsor code	GS-7977
D.3.9.3	Other descriptive name	SOFOSBUVIR
D.3.9.4	EV Substance Code	SUB121170
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	400
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VELPATASVIR
D.3.9.2	Current sponsor code	GS-5816
D.3.9.4	EV Substance Code	SUB180213
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Hepatitis C virus infection

E.1.1.1

Medical condition in easily understood language

Hepatitis C

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To evaluate the relative bioavailability of a pediatric oral granule formulation of SOF/VEL relative to tablet formulation.

To evaluate the effect of concomitant food intake on the pharmacokinetics of a pediatric granule formulation of SOF/VEL.

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of a pediatric oral granule formulation of SOF/VEL following single dose administration to healthy subjects.

To evaluate the palatability of a pediatric granule formulation.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures

2) Be aged 18 through 45 years of age, inclusive at screening

3) Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug

4) Have a calculated body mass index (BMI) of ≥ 19.0 and ≤ 30.0 kg/m2 at screening

5) Have a creatinine clearance (CLcr) ≥ 90 mL/min (using the Cockcroft-Gault method {Cockcroft 1976}) based on serum creatinine and actual body weight as measured at screening, ie,

Male: (140 – Age [years]) X (Weight [kg])
----------------------------------------------- = CLcr (mL/min)
72 X (Serum Creatinine [mg/dL])

Female: (140 – Age [years]) X (Weight [kg])
 ---------------------------------------------- X 0.85 = CLcr (mL/min)
72 X (Serum Creatinine [mg/dL])

6) Females of childbearing potential must have a negative serum pregnancy test at screening and Day -1

7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

8) Male subjects must refrain from sperm donation from Day −1), throughout the study period, and continuing for at least 30 days following the last dose of study drug and continuing for at least 30 days following the last dose of study drug

9) Subjects have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.

10) Screening laboratory and 12-lead ECG evaluations must be without clinically significant abnormalities as assessed by the investigator

11) Must be willing and able to comply with all study requirements

12) Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs.

E.4

Principal exclusion criteria

1) Lactating or pregnant female
2) Have received an investigational drug within 30 days prior to Day 1

3) Have current alcohol or substance abuse judged by the investigator to potentially interfere
with subject compliance or subject safety

4) Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody, hepatitis
B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody

5) Have poor venous access that limits phlebotomy

6) Have taken any prescription medications or over-the-counter medications, including herbal
products, within 28 days of Day 1, with the exception of vitamins and/or acetaminophen and/or
ibuprofen and/or hormonal contraceptive medications

7) Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic
agents within 3 months prior to screening or is expected to receive these agents during the study
(eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)

8) Have a history of any of the following:

a) Significant serious skin disease, such as but not limited to rash, food allergy, eczema, psoriasis, or urticaria

b) Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)

c) Known hypersensitivity to the study drugs their metabolites or to formulation excipients

d) Significant cardiac disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction < 40%), a family history of long QT syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years

e) Syncope, palpitations, or unexplained dizziness

f) Implanted defibrillator or pacemaker

g) Liver disease, including Gilbert disease

h) Liver tests such as ALT (SGPT), AST (SGOT), serum total bilirubin, or alkaline phosphatase above the upper limit of normal at Screening

i) Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions requiring prolonged (> 6 months) medical treatment.

j) Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or intestinal surgery). A history of cholecystectomy is not exclusionary.

k) Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous system, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.

9) To be, in the opinion of the Investigator, inappropriate for study participation for any reason

E.5 End points

E.5.1

Primary end point(s)

The primary endpoints are plasma PK parameters of AUCinf, AUClast, and Cmax , for SOF, GS-566500, GS-331007, and VEL.

E.5.1.1

Timepoint(s) of evaluation of this end point

Scheduled assessments points throughout the treatment period

E.5.2

Secondary end point(s)

The secondary endpoints are the incidences of AEs, laboratory abnormalities, vital signs, tolerability, and palatability.

The secondary PK endpoints are %AUCexp, Tmax, Clast, Tlast, λz, CL/F, t½, and Vz/F for SOF, GS-566500, GS-331007, and VEL, as appropriate.

E.5.2.1

Timepoint(s) of evaluation of this end point

Scheduled assessments points throughout the treatment period

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

Yes

E.6.9

Dose response

E.6.10

Pharmacogenetic

Yes

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

Yes

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

Information not present in EudraCT

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

Yes

E.8.4

Will this trial be conducted at multiple sites globally?

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

The end of this study will be the last subject’s last observation (or visit).

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

194

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

194

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Gilead may request that certain AEs be followed beyond the protocol-defined follow-up period.

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	United States

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