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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects treated with BMS-986094/INX-08189 | Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered |
| |
| Subjects treated with Placebo matching BMS-986094/INX-08189 | Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986094/INX-08189 | Drug |
|
|
| 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 |
| 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 |
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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:
Age 18 or older
Exclusion Criteria:
-
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Subjects who participated in prior trial with BMS-986094/INX-08189 and received at least 1 dose of INX-08189 or placebo in trials INH-189-002 or INH-189-006
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Los Angeles | California | 90036 | United States | ||
| Prism Research |
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| Placebo matching BMS-986094/INX-08189 | Drug |
|
|
| 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 |
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| New Orleans Center For Clinical Research - Knoxville | Knoxville | Tennessee | 37920 | United States |
| Local Institution | San Antonio | Texas | 78215 | United States |
| Local Institution | San Juan | 00927 | Puerto Rico |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C553340 | BMS-986094 |
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