Status:
COMPLETED
A Study to Determine the Relative Oral Bioavailability of Single Dose Administration of TMC207, Under Fed and Fasted Conditions in Healthy Participants
Lead Sponsor:
Tibotec BVBA
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the relative oral bioavailability (the extent to which a medication or other substance becomes available to the body as compared with another form of medicati...
Detailed Description
This is a 2-panel (2 groups), open-label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), 3- way crossover (method used to switch participan...
Eligibility Criteria
Inclusion
- Non-smoker or smokers with no more than 10 cigarettes or 2 cigars or 2 pipes per day for at least 3 months prior selection
- Normal weight as defined by a body mass index (weight in kilograms divided by the square of height in meters) of 18 to 30 kg/m2, extremes included
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality
Exclusion
- Positive tests for Human Immunodeficiency Virus 1 (HIV type 1) or HIV 2; hepatitis A, hepatitis B, or hepatitis C infection; and urine drug tests at screening
- Female with no childbearing potential
- History or current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use
- Relevant medical history or presence of systemic disease (gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory, infectious disease), or significant skin disease
- History or presence of clinically significant electrocardiogram at screening
- Abnormal laboratory values at screening
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00946842
Start Date
August 1 2009
End Date
March 1 2010
Last Update
March 19 2013
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