Clinical Trials Register

Summary
EudraCT Number:	2015-004595-29
Sponsor's Protocol Code Number:	TR701-120/MK-1986-013
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2016-01-08
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

2015-004595-29

A.3

Full title of the trial

A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old

A.3.1

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

Tedizolid PK/Safety study in children 2-12 years

A.4.1

Sponsor's protocol code number

TR701-120/MK-1986-013

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02750761

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/264/2016

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Cubist Pharmaceuticals, LLC
B.1.3.4	Country	Switzerland
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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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	Cubist Pharmaceuticals, LLC
B.5.2	Functional name of contact point	Pamela S. Sears
B.5.3	Address:
B.5.3.1	Street Address	Weystrasse 20
B.5.3.2	Town/ city	Lucerne
B.5.3.3	Post code	6006
B.5.3.4	Country	Switzerland
B.5.4	Telephone number	+1858 352 2621
B.5.6	E-mail	pamela.sears@merck.com

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	Sivextro (Tedizolid Phosphate)
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Corp.
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.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TEDIZOLID PHOSPHATE
D.3.9.1	CAS number	856867-55-5
D.3.9.3	Other descriptive name	TEDIZOLID PHOSPHATE
D.3.9.4	EV Substance Code	SUB35385
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	200
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.IMP: 2
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	No
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	Tedizolid phosphate
D.3.2	Product code	MK-1986
D.3.4	Pharmaceutical form	Powder for oral suspension
D.3.4.1	Specific paediatric formulation	Yes
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	TEDIZOLID PHOSPHATE
D.3.9.1	CAS number	856867-55-5
D.3.9.3	Other descriptive name	TEDIZOLID PHOSPHATE
D.3.9.4	EV Substance Code	SUB35385
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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

Treatment or prophylaxis against Gram-positive infections

E.1.1.1

Medical condition in easily understood language

Gram Positive Bacterial infection

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10053021
E.1.2	Term	Gram-positive bacterial infection
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Part A
1. To describe the single-administration pharmacokinetics (PK) of IV tedizolid phosphate (TZD) and its active metabolite, tedizolid, in subjects ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).
Part B
2. To describe the bioavailability of tedizolid following oral TZD administration to subjects ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4).

E.2.2

Secondary objectives of the trial

Part A
1. To evaluate the safety and tolerability of IV TZD administration in subjects ages 6 to <12 years (Group 1) and 2 to <6 years (Group 2).
Part B
2. To evaluate the safety and tolerability of oral TZD administration in subjects ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4).
3. To evaluate the palatability of oral TZD suspension in subjects ages 6 to <12 years (Group 3) and 2 to <6 years (Group 4).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Aged 2 to <12 years at the time of consent
2. Receiving prophylaxis for or with a confirmed or suspected infection with Gram-positive bacteria and receiving concurrent antibiotic treatment with Gram-positive antibacterial activity
3. Weight >5th percentile and <95th percentile based on age
4. Stable condition as determined from medical history, physical examination, ECG (minimally 5-lead), vital signs, and clinical laboratory evaluations
5. No clinically significant ECG abnormalities in the judgment of the Investigator
6. Serum creatinine within 1.5 × upper limit of reference range based on age
7. Females must be pre-menarchal, abstinent, or practicing an effective method of birth control
8. Negative blood or urine beta-human chorionic gonadotropin pregnancy test (if urine test is used, it must be high sensitivity [i.e., able to detect 10 mIU/mL β-hCG]) at the Screening Visit (post-menarchal females only)
9. Subjects and parents must be willing to adhere to the prohibitions and restrictions specified in this protocol
10. Parents or subjects’ LAR able to give informed consent and willing and able to comply with all required study procedures. Assent is also required of children capable of understanding the nature of the study (typically ≥7 years old)

E.4

Principal exclusion criteria

1. History of seizures, other than febrile seizures, clinically significant cardiac arrhythmia, cystic fibrosis, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator
2. Use of rifampin within 14 days prior to study drug administration
3. Use of ranitidine, cimetidine, and antacids for subjects in Part B (oral administration) from 24 hours prior to study drug administration and throughout the study
4. Recent (3 month) history or current infection with viral hepatitis or other significant hepatic disease
5. History of drug allergy or hypersensitivity to oxazolidinones
6. Pregnant or breast feeding
7. Significant blood loss (≥5% of total blood volume) within 60 days before the Screening Visit
8. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject’s ability to complete and/or participate in this clinical study
9. Treatment with investigational medicinal product within 30 days before the infusion/dose of study drug
10. Need for oral administration of methotrexate, topotecan, irinotecan or rosuvastatin, during administration of oral study drug. (Administration during the follow-up period is allowed, as is administration during treatment with IV study drug.)
11. Use of monoamine oxidase inhibitors or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors, and serotonin 5 hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within,14 days prior to study, or planned use while on study

E.5 End points

E.5.1

Primary end point(s)

- The pharmacokinetics of tedizolid phosphate and its active metabolite
- Bioavailability

E.5.1.1

Timepoint(s) of evaluation of this end point

- Evaluate PK of tedizolid phosphate and its active metabolite up to 24 hours after the start of infusion in children ages 6 to <12 years; and 48 hours (unless discharged after 24 hours sample, then it will be 24 hours) after the start of infusion in childrent 2 to <6 years.
- Evaluate bioavailability of tedizolid up to 24 hours after the oral study drug administration in children ages 6 to <12 years; and 48 hours (unless discharged after 24 hours sample, then it will be 24 hours) after the oral study drug administration in childrent 2 to <6 years .

E.5.2

Secondary end point(s)

Safety and tolerability

E.5.2.1

Timepoint(s) of evaluation of this end point

The safety and tolerability of IV and oral tedizolid phosphate in children ages 6 to <12 and 2 to <6 years will be evaluated at 7 Day after the study drug administration; and palatability will be evaluated after oral tedizolid phosphate administration in children ages 6 to <12 and 2 to <6 years.

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

E.6.9

Dose response

E.6.10

Pharmacogenetic

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

E.7.1.3

Other

Yes

E.7.1.3.1

Other trial type description

Pharmacokinetic and Safety Study

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

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

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.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

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

Australia

Colombia

Ukraine

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

LVLS

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

F.3.2

Patients

Yes

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

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)

None

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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