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)

NCT ID: NCT02674581

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-26
• Study Completion Date: 2016-05-24

Brief Summary

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

Conditions

HIV Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy Subjects

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

Group Type: EXPERIMENTAL

Oral BMS-663068 (pro-drug)

Intervention Type: DRUG

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

Mild Renal Impairment Subjects

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

Group Type: EXPERIMENTAL

Oral BMS-663068 (pro-drug)

Intervention Type: DRUG

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

Moderate Renal Impairment Subjects

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

Group Type: EXPERIMENTAL

Oral BMS-663068 (pro-drug)

Intervention Type: DRUG

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

Severe Renal Impairment Subjects

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

Group Type: EXPERIMENTAL

Oral BMS-663068 (pro-drug)

Intervention Type: DRUG

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

End Stage Renal Disease Subjects

A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.

Group Type: EXPERIMENTAL

Oral BMS-663068 (pro-drug)

Intervention Type: DRUG

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

Interventions

Oral BMS-663068 (pro-drug)

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

ViiV Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

ViiV Healthcare

Locations

GSK Investigational Site

Miami, Florida, United States

Countries

United States

Other Identifiers

AI438-070

Identifier Type: OTHER

Identifier Source: secondary_id

206217

Identifier Type: -

Identifier Source: org_study_id