A Phase I randomized, open-label, single dose, 4-period crossover study in healthy subjects to evaluate the relative oral bioavailability of two tablet strengths of TMC125 and the effect of coating on bioavailability.
- Conditions
- HIV-1 Infection10047438
- Registration Number
- NL-OMON31927
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Permission in writing to participate in this trial;
Aged between 18 and 55 years;
A good physical and mental condion;
Normal weight for your length;
No abnormalities found at screening;
Non-smoking;
Females should be post-menopausal for at least 2 years, or have had a hystorectomy, or tubal ligation (without reversal operation).
if you use of drugs and/or have a history of alcohol abuse;
If you have had a have had a surgical operation in the past three months;
If you have developed a rash as a result of participation in another trial with TMC125/TMC120/TMC278;
If you have participated in another medical trial within the past three months;
If you have doneted blood within the past 60 days;
If you are hepatitis A, B, C or HIV-1 or HIV-2 positive;
If you are in the opinion of the physician not fit to participate in this trial;
If you used prescription medication in the 14 day before admission;
If oyu used over the counter drugs in the 7 days before intake of the trial medication. This includes herbal suplements, dieting suplements, garlic suplements and vitamines ( except for paracetamol and ibuprefen, which can be used up to 3 days before first intake of trial mediaction);
Any history of significant skin disease such as, but not limited to, rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis, or urticaria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>In each session, full pharmacokinetic profiles of TMC125 will be determined up<br /><br>to 96 hours after administration.<br /><br>Safety and tolerability will be assessed on an ongoing basis until 30 - 32 days<br /><br>after last drug intake.<br /><br>Blood and urine tests, adverse events, safety laboratory parameters, vital<br /><br>signs, heart rate, ECG, alcohol breath tests, urine drug screen tests and<br /><br>pregancy test (female only).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>