Phase I, double-blind, randomized, placebo-controlled trial in healthy volunteers to examine the safety, tolerability and plasma pharmacokinetics of TMC589337 and TMC589354 after increasing single oral doses and in an open-label part after different repeated oral doses in combination with a single oral dose of TMC310911.
- Conditions
- AIDSHIV10021460
- Registration Number
- NL-OMON33338
- Lead Sponsor
- Tibotec Pharmaceuticals, EastGate Village, Eastgate, Little Island, CO Cork, Ireland, In Nederland vertegenwoordigd door Janssen-Cilag B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
1. Subjects aged between 18 and 55 years, extremes included.
2. Non smokers for at least 3 months prior to selection.
3. Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included.
4. Informed consent signed voluntarily.
5. Able to comply with protocol requirements.
6. Healthy on basis of a pre-trial physical examination, medical history, the results of blood biochemistry and hematology tests, a urinalysis, vital signs and an ECG.
1. Past history of significant heart arrhythmias.
2. Female, except if postmenopausal for more than 2 years, or posthysterectomy or post-surgical sterilization (without reversal operation).
3. History of alcohol or drug abuse.
4. Hepatitis A, B or C infection of HIV-1 or HIV-2 infection at trial screening.
5. A positive urine drug test at screening.
6. Currently active clinically relevant or significant underlying gastro-intestinal-, cardiovascular-, nervous system-, psychiatric-, metabolic-, renal-, hepatic-, respiratory-, inflammatory-, or infectious disease.
7. History of clinically relevent skin disease such as but not limited to dermatitis, eczema, drug allergy, psoriasis, food allergy, urticaria.
8. History of drug allergy such as but not limited to sulfonamides and penicillins or drug allergy witnessed in previous trials with experimental drugs.
9. Use of concomitant medication, except for paracetamol (acetaminophen) and ibuprofen in a period of 14 days before the first trial medication intake.
10. Participation in an investigational drug trial within 90 days (after last intake) prior to the first intake of trial medication.
11. Donation of blood or plasma in the 60 days preceding the first intake if trial medication.
12. Subjects with lababnormalities at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The safety, tolerability and behavior in the body (absorption and excretion) of<br /><br>oral intake of TMC589337 and TMC589354 after ascending single intakes.<br /><br><br /><br>The safety, tolerability and behavior in the body after multipe dose intakes of<br /><br>TMC589337 and/or TMC589354 in combination with a single dose of TMC310911 will<br /><br>be examined.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not applicable.</p><br>