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)

ViiV Healthcare

Status and phase: Completed; Phase 1

Conditions: HIV Infections

Treatments: Drug: Oral BMS-663068 (pro-drug)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02674581

206217

AI438-070 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 5 patient groups

Healthy Subjects

Experimental group

Description:

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

Treatment:

Drug: Oral BMS-663068 (pro-drug)

Mild Renal Impairment Subjects

Experimental group

Description:

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

Treatment:

Drug: Oral BMS-663068 (pro-drug)

Moderate Renal Impairment Subjects

Experimental group

Description:

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

Treatment:

Drug: Oral BMS-663068 (pro-drug)

Severe Renal Impairment Subjects

Experimental group

Description:

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

Treatment:

Drug: Oral BMS-663068 (pro-drug)

End Stage Renal Disease Subjects

Experimental group

Description:

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

Treatment:

Drug: Oral BMS-663068 (pro-drug)