Healthy, Hepatitis C
Conditions
Keywords
Volunteers
Brief summary
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
Interventions
DRUGBMS-986094/INX-08189
DRUGPlacebo matching BMS-986094/INX-08189
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 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 | Up to Day 90 |
Secondary
| Measure | Time frame |
|---|---|
| Abnormalities in B-type-natriuretic peptide (BNP) levels that may be associated with prior exposure to single or multiple oral doses of BMS-986094 | 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 | 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 | By Day 7 |
| 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) | Baseline (pre-dose Day 1 ECG from parent study) and By Day 30 |
| Abnormalities in creatine phosphokinase (CPK) and creatine phosphokinase-metabolic (CPK-MB) levels that may be associated with prior exposure to single or multiple doses of BMS-986094 | By Day 30 |
| Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094 | By Day 30 |
| 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 | By Day 90 |
| 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 | By Day 90 |
Countries
Puerto Rico, United States
Outcome results
None listed