A Study of the Pharmacokinetics and Safety of BMS-663068 Administered in Subjects With Normal Renal Function and With Mild, Moderate, Severe and End Stage Renal Dysfunction (ESRD)
An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-Stage Renal Dysfunction
2 other identifiers
interventional
30
1 country
1
Brief Summary
An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
Started Feb 2016
Shorter than P25 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
February 4, 2016
CompletedStudy Start
First participant enrolled
February 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2016
CompletedMay 15, 2018
May 1, 2018
3 months
December 21, 2015
May 9, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Day 1 - Day 5
Secondary Outcomes (1)
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.
Day 1 - Day 5
Study Arms (5)
Healthy Subjects
EXPERIMENTALA single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Mild Renal Impairment Subjects
EXPERIMENTALA single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Moderate Renal Impairment Subjects
EXPERIMENTALA single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Severe Renal Impairment Subjects
EXPERIMENTALA single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
End Stage Renal Disease Subjects
EXPERIMENTALA single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
Interventions
Oral BMS-663068 (pro-drug), metabolized to active BMS-626529
Eligibility Criteria
You may qualify if:
- Classification by renal function based on eGFR
- Clinical, ECG, and laboratory findings consistent with renal dysfunction
- BMI of 18.0 to 38.0 kg/m2 inclusive
- Women of child bearing potential (WOCBP) and sexually active fertile men with partners who are WOCBP must use non-hormonal highly effective birth control
You may not qualify if:
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
- Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months
- Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug
- Any major surgery within 4 weeks of study drug administration.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ViiV Healthcarelead
- GlaxoSmithKlinecollaborator
Study Sites (1)
GSK Investigational Site
Miami, Florida, 33014, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
ViiV Healthcare
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2015
First Posted
February 4, 2016
Study Start
February 26, 2016
Primary Completion
May 24, 2016
Study Completion
May 24, 2016
Last Updated
May 15, 2018
Record last verified: 2018-05