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

Study Overview
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Brief Summary
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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

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

Conditions
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Healthy, Hepatitis C

Intervention / Treatment
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* Drug: BMS-986094/INX-08189
* Drug: Placebo matching BMS-986094/INX-08189


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects treated with BMS-986094/INX-08189<br>Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered | Drug: BMS-986094/INX-08189<br> <br> * Other names: Observational study - No Intervention subjects were previously treated with BMS-986094/INX-08189;|
| Subjects treated with Placebo matching BMS-986094/INX-08189<br>Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered | Drug: Placebo matching BMS-986094/INX-08189<br> <br> * Other names: Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 | 
| 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 | 
| 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volunteers