AIDS HIV
Conditions
Interventions
In Treatment A, a single oral dose equivalent to 800 mg TMC114 and 94,64 mg
TMC41629 of the immediate-release coformulation (4 capsules) will be
administered.
In Treatment B, a single oral dose eq
Sponsors
Tibotec Pharmaceuticals Ltd, EastGate Village, Eastgate, Little Island, CO Cork, Ireland, In Nederland vertegenwoordigd door Janssen-Cilag B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male subjects, aged between 18 and 55 years, extremes included. 2. Non-smoking for at least 3 months prior to selection. 3. Normal weight as defined by a Body Mass Index (BMI, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included. 4. Informed Consent Form (ICF) signed voluntarily before the first trial-related activity. 5. Able to comply with protocol requirements. 6. Healthy on the basis of a medical evaluation that confirms the absence of any clinically relevant abnormality and includes a physical examination, medical history, labresults and an ECG (in triplicate).
Exclusion criteria
Exclusion criteria: 1. Past history of heart arrhythmias (extrasystoli, tachycardia at rest). 2. History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator*s opinion would compromise subject*s safety and/or compliance with the trial procedures. 3. Hepatitis A, B, or C infection (confirmed by hepatitis A antibody IgM, hepatitis B surface antigen, or hepatitis C virus antibody, respectively), or HIV-1 or HIV-2 infection at screening. 4. A positive urine drug test at screening. Urine will be tested to check the current use of amphetamines, benzodiazepines, cocaine, cannabinoids, and opioids. 5. Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, endocrinologic, genitourinary, renal, hepatic, respiratory, inflammatory, or infectious disease. 6. Currently significant diarrhea, gastric stasis, or constipation that in the investigator*s opinion could influence drug absorption or bioavailability. 7. Any history of significant skin disease such as, but not limited to, rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, folliculitis or urticaria. 8. History of significant allergy to drugs such as, but not limited to, sulfonamides and penicillines. 9. Use of concomitant medication, including over-the-counter products, herbal preparations and dietary supplements. Concomitant medication must have been discontinued at least 14 days before the first dose of trial medication intake except for paracetamol (acetaminophen (see Section 5.3.9). 10. Participation in an investigational drug trial within 90 days prior to the first intake of trial medication. 11. Donation of blood or plasma within 60 days preceding the first intake of trial medication. 12. Having previously participated in a multiple-dose trial with TMC114. 13. Having previously participated in more than 3 single-dose trials with TMC114. 14. Subjects with laboratory abnormalities at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessing the impact of controlled-release properties on the plasma concentration-time profiles and relative bioavailability of TMC114 and TMC41629 of 2 different controlled-release formulations of combinations TMC114/TMC41629 to compare with a coformulation immediate release of TMC114/TMC41629 in healthy male subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The determination of plasma pharmacokinetics of TMC114 and TMC41629 for 2 different controlled-release formulation TMC114/TMC41629 and a combination of immediate-release coformulation of TMC114/TMC41629 in healthy male subjects. - The short-term assessment of the safety and tolerability of TMC114/TMC41629 followed by 3 administrations of single oral doses (expressed as different coformulaties of TMC114/TMC41629) in healthy male subjects. | — |
Countries
Netherlands
Outcome results
None listed