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A Study to Assess the Drug-Drug Interaction Between VX-787 and Oseltamivir

Information source: Janssen Infectious Diseases BVBA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: VX-787 (Drug); Oseltamivir (Drug); Placebo (Other)

Phase: Phase 1

Status: Completed

Sponsored by: Janssen Infectious Diseases BVBA

Official(s) and/or principal investigator(s):
Janssen Infectious Diseases BVBA Clinical Trial, Study Director, Affiliation: Janssen Infectious Diseases BVBA

Summary

The purpose of this study is to investigate the drug-drug interaction between VX-787 and oseltamivir, when co-administered at steady-state in healthy participants. In addition the safety, tolerability and pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of VX-787 will be assessed.

Clinical Details

Official title: A Phase 1, Randomized, 3-way Crossover, Open-label Study to Assess the Drug-drug Interaction Between VX-787 and TamifluŽ, Followed by a Double-blind, Randomized, Placebo-controlled Study to Collect Safety, Tolerability and Pharmacokinetics of VX-787, in Healthy Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome:

Assess the drug-drug interaction between VX-787 600 mg bid coadministered with oseltamivir 75 mg bid at steady-state in healthy participants

Evaluate the safety and tolerability of a VX-787 600 mg bid regimen during 10 days in healthy participants

Assessment of Pharmacokinetics of VX-787

Secondary outcome: Investigate the short-term safety and tolerability of the concomitant use of VX-787 and oseltamivir in healthy participants

Detailed description: This study consists of 2 parts. Part 1 is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving), randomized (treatment group assigned by chance), 3-way crossover (a method used to switch participants from one treatment group to another in a clinical trial) study to estimate drug-drug interaction between VX-787 and oseltamivir. It consists of 3 phases: a Screening phase, a Treatment phase and a Follow-up phase. Treatment phase will include 3 treatment sessions, each of the participant will receive Treatment A (VX-787, 600 milligram [mg] 2 times a day on Day 1 to 4, followed by a single dose of VX 787, 600 mg on Day 5); Treatment B (Oseltamivir, 75 mg 2 times a day on Day 1 to 4, followed by a single dose of oseltamivir 75 mg on Day 5) and Treatment C (VX-787, 600 mg 2 times a day + oseltamivir, 75 mg 2 times a day on Day 1 to 4, followed by a single dose of VX-787, 600 mg + a single dose of oseltamivir, 75 mg on Day 5). Each treatment session will be separated by a wash-out period of 5 days. The order each participant will receive treatments A, B and C will be decided at randomization. Part 2 is double-blind (a medical research study in which neither the researchers nor the participants know what treatment the subjects is receiving), randomized, placebo-controlled. It consists of 3 phases: a Screening phase, a Treatment phase and a Follow-up phase. In Treatment phase participants will be randomly assigned VX-787, 600 mg or placebo 2 times a day, on Day 1 to 9, followed by a single dose of VX-787 600 mg or placebo in the morning on Day 10. Pharmacokinetic parameters will be assessed primarily. Participants' safety will be monitored throughout the study.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Female participants must be of non-childbearing potential: postmenopausal for at

least 2 years (amenorrheal for at least 3 years and a serum follicle stimulating hormone [FSH] level greater than [>] 40 international unit per liter [IU/L]), or surgically sterile (have had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant

- Participants must be non-smoking or smoking no more than 10 cigarettes, or 2 cigars,

or 2 pipes per day for at least 3 months prior to screening

- Participants must have a Body Mass Index (BMI: weight in kg divided by the square of

height in meters) of 18. 0 to 30. 0 kilogram per meter square [kg/m^2]

- Participants must be willing/able to adhere to the prohibitions and restrictions

specified in the protocol and study procedures

- Participants must be healthy on the basis of a medical evaluation that reveals the

absence of any clinically significant abnormality and includes a physical examination, medical history, vital signs and the results of blood biochemistry, blood coagulation and hematology test and a urinalysis performed at screening Exclusion Criteria:

- Participants with a past history of heart arrhythmias (for example, extrasystoli,

tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)

- Participants with a history or evidence of use of alcohol, barbiturates,

amphetamines, recreational or narcotic drug use within the past 1 year, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures

- Participants with current hepatitis A infection (confirmed by hepatitis A antibody

immunoglobulin M [IgM]), or hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at study screening

- Participants having a positive urine drug test or alcohol breath test at study

screening. Urine will be tested for the presence of amphetamines, benzodiazepines, cocaine, cannabinoids, opioids, methadone and barbiturates

- Participants with known allergies, hypersensitivity, or intolerance to VX-787,

oseltamivir, or excipients of the drug products used

Locations and Contacts

Merksem, Belgium
Additional Information

Starting date: July 2014
Last updated: November 3, 2014

Page last updated: August 23, 2015

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