A Phase 1 interventional study of BMS-663068 and Darunavir in Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-24.
Sponsored by ViiV Healthcare · Phase 1, Interventional, and Treatment
This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male and female subjects. There is no formal hypothesis, however, it is expected that the coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase the systemic exposure of BMS-626529.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 32 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment A: BMS-663068 orally twice daily (BID) on Days 1 through 4 Treatment B: BMS-663068 orally BID plus DRV/COBI orally once daily (QD) on Days 5 through 14
Drug: BMS-663068 · Drug: Darunavir · Drug: Cobicistat
Treatment C: BMS-663068 orally BID on Days 1 through 4 Treatment D: BMS-663068 orally BID plus COBI QD on Days 5 through 14
Drug: BMS-663068 · Drug: Cobicistat
BMS-663068
Darunavir
Cobicistat
Pharmacokinetic parameters (maximum observed plasma concentration and area under the concentration-time curve in 1 dosing interval) for BMS-626529
In the presence or absence of multiple doses of DRV/COBI or COBI
Time frame: predose and up to 12 hours post dose on Days 4 and 14
Safety as assessed by adverse events and other physical parameters
Collection of adverse events and other physical parameters to assess safety and tolerability
Time frame: From dosing (Day 1) to Day 14
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
ViiV Healthcare