Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911.
- Conditions
- AIDSHIV1002146010047438
- Registration Number
- NL-OMON33802
- 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
- 54
1) 18-60 years;
2) Nonsmoker;
3) BMI 18.0-30.0;
4) Signed ICF
5) Able to comply with protocol requirements
6) Healthy based on the basis of a medical evaluation.
1) History of clinically significant heart arrhythmias;
2) Female except if they are of non-childbearing potential;
3) History or evidence of alcohol and or drug abuse ;
4) Hepatitis A, B en C;
5) Positive urine drug test;
6) Currently active or underlying gastrointestinal, cardiovascular, neurologic, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease;
7) Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria
8) History of drug allergy;
9) Use of concomitant medication, except for paracetamol and ibuprofen in the 14 before first trial medication intake;
10) Participation in an investigational drug trial within 60 days prior to the first intake of trial medication;
11) Donation of blood plasma within the 60 days preceding the first intake of trial medication;
12) Lab abnormalities.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method