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Sponsored by: |
Tibotec Pharmaceuticals Limited, Ireland |
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Information provided by: | Tibotec Pharmaceuticals Limited, Ireland |
ClinicalTrials.gov Identifier: | NCT00744887 |
The objectives are to determine the effect of different ritonavir doses on darunavir (DRV) oral exposure following once-daily oral dosing of DRV/rtv for 7 days, in order to establish an optimal ritonavir boosting dose for DRV and to evaluate short-term safety and tolerability.
Condition | Intervention | Phase |
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HIV AIDS |
Drug: Darunavir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Phase I, Open-Label, Randomized, 3-Way Crossover Trial to Assess the Pharmacokinetics of Darunavir (DRV) Given Once-Daily With Different Doses of Ritonavir in Healthy Subjects. |
Estimated Enrollment: | 18 |
Study Start Date: | August 2008 |
This is a Phase I, open-label, randomized (study drug assigned by chance), 3-way crossover trial in healthy volunteers to assess the pharmacokinetics of darunavir (DRV), co-administered with different doses of ritonavir. The trial population will consist of 18 healthy adult volunteers. During 3 subsequent sessions, each volunteer will receive in a randomized way: Treatments A, B and C. In Treatment A, 800 mg DRV once-daily and 100 mg ritonavir once-daily will be administered. In Treatment B, 800 mg DRV once-daily and 50 mg ritonavir once-daily will be administered. In Treatment C, 800 mg DRV once-daily and 20 mg ritonavir once-daily will be administered. All treatments will be administered for 7 days and intake of DRV and ritonavir will be under fed conditions. DRV will be formulated as a 400 mg tablet; ritonavir will be formulated as an oral solution containing 80mg/mL ritonavir. In each treatment session, full pharmacokinetic profiles of DRV and ritonavir will be determined up to 24 hours after administration on Day 1 and up to 72 hours after administration on Day 7. There will be a washout period of at least 7 days between subsequent treatments. Safety and tolerability will be evaluated continuously throughout the trial.
During 3 subsequent sessions, each volunteer will receive in a randomized way Treatments A, B and C. In Treatment A, 800/100 mg DRV/rtv once-daily will be administered. In Treatment B, 800/50 mg DRV/rtv once-daily will be administered. In Treatment C, 800/20 mg DRV/rtv once-daily will be administered. All treatments will be administered for 7 days. DRV will be formulated as a 400 mg tablet; ritonavir will be formulated as an oral solution containing 80mg/mL ritonavir.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR015421 |
Study First Received: | August 29, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00744887 |
Health Authority: | United States: Food and Drug Administration |
TMC114-TiDP3-C181 TMC114-C181, health volunteers, Darunavir, ritonavir oral solution |
Ritonavir HIV Infections Acquired Immunodeficiency Syndrome Healthy Darunavir |
Anti-Infective Agents HIV Protease Inhibitors Anti-HIV Agents Anti-Retroviral Agents Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Antiviral Agents Pharmacologic Actions Protease Inhibitors |