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

Completed

• Conditions: Healthy; Hepatitis C
• Interventions: Drug: Placebo matching BMS-986094/INX-08189; Drug: BMS-986094/INX-08189

• Registration Number: NCT01732848
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-26
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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

Read More

Exclusion Criteria

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects treated with Placebo matching BMS-986094/INX-08189	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
Subjects treated with BMS-986094/INX-08189	BMS-986094/INX-08189	Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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 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
Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094	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
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

Trial Locations

Locations (3)

Local Institution; 🇵🇷 San Juan, Puerto Rico

New Orleans Center For Clinical Research - Knoxville; 🇺🇸 Knoxville, Tennessee, United States

Prism Research; 🇺🇸 St. Paul, Minnesota, United States