A Phase I, open-label, randomized, 3-way crossover study in 3 Panels of healthy, adult subjects to assess the relative bioavailability of TMC207 following single-dose administration of two pediatric formulations using a 100 mg tablet formulation as the reference, with and without food.
- Conditions
- 10004018tuberculosis
- Registration Number
- NL-OMON38686
- Lead Sponsor
- Janssen Infectious Diseases BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
1)Healthy participant on the basis of physical examination, medical history, vital signs, and electrocardiogram (ECG), and the results of blood biochemistry and hematology tests and a urinalysis performed at screening;2)Must have a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included ;3)Women must be postmenopausal for at least 2 years.;4) Participants must be non-smokers for at least 3 months prior to screening
1) Human immunodeficiency virus - type 1 (HIV-1) or type 2 (HIV-2) infection confirmed at screening -Hepatitis A, B or C infection confirmed at screening ;2) A positive urine drug test or alcohol breath test at screening. ;3) History or any currently active disease or condition that the Investigator considers to be clinically significant.;4) Abnormalities in laboratory tests determined at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>bioavailability</p><br>
- Secondary Outcome Measures
Name Time Method <p>safety, PK</p><br>