A Phase 1 interventional study of Oral BMS-663068 (pro-drug) in HIV Infections, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-15.
Sponsored by ViiV Healthcare · Phase 1, Interventional, and Treatment
An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 30 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency 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:
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Drug: Oral BMS-663068 (pro-drug)
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Drug: Oral BMS-663068 (pro-drug)
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Drug: Oral BMS-663068 (pro-drug)
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Drug: Oral BMS-663068 (pro-drug)
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Drug: Oral BMS-663068 (pro-drug)
Oral BMS-663068 (pro-drug), metabolized to active BMS-626529
Effect of Renal Impairment on The Primary Endpoints of Cmax
To assess the effect of varying degrees of renal impairment on the exposure of BMS-626529 after a single oral-dose administration of the pro-drug, BMS-663068, will be evaluated by assessing the primary endpoints of Cmax, for BMS-626529.
Time frame: Day 1 - Day 5
Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests.
To assess the safety and tolerability of BMS-663068 in subjects with normal renal function and subjects with impaired renal functions, will be measured by the following secondary endpoints: Incidence of AEs, Serious Adverse Events (SAEs), and AEs leading to discontinuation, and results of vital signs, ECGs, physical examination, and clinical laboratory tests.
Time frame: Day 1 - Day 5
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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ViiV Healthcare