A Phase I, open-label trial to investigate the pharmacokinetic interaction between TMC125 and two antifungal agents (fluconazole and voriconazole), all at steady-state in healthy subjects.
- Conditions
- AIDSHIV10021460
- Registration Number
- NL-OMON32571
- Lead Sponsor
- Tibotec Pharmaceuticals Ltd, 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
- 18
1. Aged between 18 and 55 years, extremes included.
2. Non-smoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to screening.
3. Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, extremes included.
4. Informed Consent Forms signed voluntarily before first trial-related activity.
5. Able to comply with protocol requirements.
6. Healthy on the basis of medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including skin examination), medical and surgical history, electrocardiogram (ECG), vital signs and the results of blood biochemistry, hematology and a urinalysis carried out at screening.
1. A positive HIV-1 or HIV-2 result at study screening.
2. Females who are not postmenopausal since more than two years, or not had a post-hysterectomy or are not surgically sterilized (without reversal operation).
3. 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 study procedures.
4. A positive Hepatitis A, B or C result at study screening.
5. A positive urine drug test at study screening or on Day -1 of each session.
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 fluconazole, voriconazole and/or any of the excipients of the investigational medication administered on this trial.
10. A history of heart disease.
11. Clinically relevant heart rhythm disturbances.
12. High bloodpressure.
13. History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
14. 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 medication and all products containing Hypericum Perforatum must have been discontinued at least 14 days before the first dose of study medication, except for paracetamol.
15. Participation in an investigational drug trial within 60 days prior to the first intake of trial medication.
16. Donation of blood plasma within the 60 days preceding the first intake of trial medication.
17. 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.
18. Subjects with laboratory abnormalities.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The effect of steady state concentrations of voriconazole and fluconazole on<br /><br>the steady-state pharmacokinetics of TMC125.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The effect of steady-state concentrations of TMC125 on the steady-state<br /><br>pharmacokinetics of voriconazole and fluconazole.<br /><br><br /><br>Short-term safety and tolerability of the coadministration of voriconazole or<br /><br>fluconazole and TMC125.</p><br>