A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)

Bristol-Myers Squibb113 enrolled

Overview

The purpose of this study is to determine the rate of kidney or heart impairment, if any, in subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials

Study Type

OBSERVATIONAL

Enrollment

113

Conditions

Healthy Hepatitis C

Interventions

BMS-986094/INX-08189DRUG

Placebo matching BMS-986094/INX-08189DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase 1 trial with BMS-986094/INX-08189 and: 1. Received at least 1 dose of INX-08189 or 2. Received placebo in studies for HCV-infected subjects (INH-189-002 or INH-189-006) * Age 18 or older Exclusion Criteria: \-

Locations (5)

Local Institution

Los Angeles, California, United States

Prism Research

Saint Paul, Minnesota, United States

New Orleans Center For Clinical Research - Knoxville

Knoxville, Tennessee, United States

Local Institution

San Antonio, Texas, United States

Outcomes

Primary Outcomes

Rate of renal impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired renal function and require referral to a nephrologist

Time frame: Up to Day 90

Rate of cardiac impairment among subjects exposed to BMS-986094 in the Phase 1 program that meet the predefined criteria for impaired cardiac function and require referral to a cardiologist

Time frame: Up to Day 90

Secondary Outcomes

Changes in the electrocardiographic parameters observed in association with prior exposure to single and multiple oral doses of BMS-986094 compared to pre-exposure electrocardiograms (ECGs)

Time frame: Baseline (pre-dose Day 1 ECG from parent study) and By Day 30

Abnormalities in cardiac ejection fraction (EF) as determined by trans-thoracic echocardiogram that may be associated with prior exposure to single or multiple oral doses of BMS-986094

Time frame: By Day 90

Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094

Time frame: By Day 30

Changes in serum creatinine levels compared to pre-exposure levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094

Time frame: Baseline (Day 1 from parent study) and By Day 14

Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094

Time frame: By Day 7

Presence of signs, symptoms or medical history suggestive of heart failure or renal failure that may have been observed since last exposure to BMS-986094

Data from ClinicalTrials.gov

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