NCT02262715

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Janssen Infectious Diseases BVBA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	VX-787	Participants will receive VX-787, 600 mg either two times a day or once a day in either of the Part.
DRUG	Oseltamivir	Participants will receive Oseltamivir 75 mg either two times a day or once a day in either of the Part.
OTHER	Placebo	Participants will receive placebo matching to VX-787 either two times a day or or once a day.

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-10-13
• Last updated: 2014-11-04

Locations

1 site across 1 country: Belgium