A Phase 1 interventional study of Darunavir in HIV and AIDS, sponsored by Tibotec Pharmaceuticals, Ireland. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-09.
Sponsored by Tibotec Pharmaceuticals, Ireland (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
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.
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 21 is below the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Tibotec Pharmaceuticals, Ireland is the lead sponsor of 77 studies on the registry; none are open to participants now.
First submitted after Tibotec Pharmaceuticals, Ireland became part of Johnson & Johnson.
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To determine the effect of different ritonavir doses (20, 50, 100 mg ritonavir) in 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
To evaluate short-term safety and tolerability of DRV following administration of DRV 800 mg once-daily in the presence of different doses of ritonavir for 7 days in healthy volunteers
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The record gives a start of Aug 2008, a primary completion of Dec 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Darunavir
Acquired Immunodeficiency Syndrome →
Tibotec Pharmaceuticals, Ireland →