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)

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02674581
• Other study ID #: 206217
• Secondary ID: AI438-070
• Status: Completed
• Phase: Phase 1
• Start date: February 26, 2016
• Est. completion date: May 24, 2016

Study information

• Verified date: May 2018
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 24, 2016
• Est. primary completion date: May 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (For renal impaired subjects):

• 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

• Slightly different inclusion criteria are defined in the protocol for healthy subjects

Exclusion Criteria:

• 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.

• Other protocol defined exclusion criteria could apply

Related Conditions & MeSH terms

• HIV Infections
• Renal Insufficiency

Intervention

Drug:
• Oral BMS-663068 (pro-drug)
Oral BMS-663068 (pro-drug), metabolized to active BMS-626529

Locations

Country	Name	City	State
United States	GSK Investigational Site	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 1 - Day 5