Status:
COMPLETED
A Study to Assess the Drug-Drug Interaction Between VX-787 and Oseltamivir
Lead Sponsor:
Janssen Infectious Diseases BVBA
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02262715
Start Date
July 1 2014
End Date
October 1 2014
Last Update
November 4 2014
Active Locations (1)
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1
Merksem, Belgium