AIDS HIV
Conditions
Interventions
Dosing with 25 mg TMC278 per treatment.
Sponsors
Tibotec Pharmaceuticals, 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) Age between 18 and 55 years 2) Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes a day for at least 3 months prior to selection. 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.
Exclusion criteria
Exclusion criteria: 1) Positive HIV and Hepatitis testresults. 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) Currently significant diarrhea, gastric stasis or constipation that in the investigator's opinion could influence drug absorption or bioavailability. 8) Any history of significant skin disease such as but not limited to rash or eruptions, drug allergies, food allergy, dermatitis, eczema, psoriasis or urticaria. 9) Previously demonstrated clinically significant allergy or hypersensitivity to and/or any of the excipients of the investigational medication administered on this trial. 10) Use of concomitant medication, including over-the-counter products and dietary supplements. Systemic over-the-counter medication must have been discontinued at least 7 days prior to the first dose of study medication; prescribed medications must have been discontinued at least 14 days before the first dose of study medication, except for paracetamol and ibuprofen. 11) Participation in an investigational drug trial within 60 days prior to the first intake of trial medication. 12) Donation of blood plasma within the 60 days preceding the first intake of trial medication. 13) Lab abnormalities 14) Having participated in more than 1 trial (single or multiple dose) with TMC125 (etravine), TMC120 (dapirivine) and/or TMC278 (rilpivirine, formerly known as R278474) or having developed rash, erythema or urticaria while participating in a trial with the aforementioned compounds. 15) Significant heart rhythm disturbances. 16) Subjects with ageusia, hypogeusia or dysgeusia 17) Renal impairment: calculated creatinine clearance (CLCr)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the oral bioavailability of 3 concept pediatric formulations of TMC278 (solution, suspension, granules) to that of the adult 25 mg Phase III tablet formulation. In addition, the absorption of TMC278 into the body will be compared when the pediatric formulations are administered on an empty stomach and after a breakfast. | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety and tolerability of TMC278 different formulations during the study period to be assessed. Finally, the palatability of each concept pediatric formulation under fasted conditions will be evaluated. | — |
Countries
Netherlands
Outcome results
None listed