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NCT01732848 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01732848
Other study ID # AI472-013
Secondary ID
Status Completed
Phase N/A
First received November 20, 2012
Last updated August 13, 2014
Start date November 2012
Est. completion date June 2014

Study information
Verified date August 2014
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 113
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Intervention

Drug:
• BMS-986094/INX-08189

• Placebo matching BMS-986094/INX-08189

Locations
Country Name City State
Puerto Rico Local Institution San Juan
United States New Orleans Center For Clinical Research - Knoxville Knoxville Tennessee
United States Local Institution Los Angeles California
United States Local Institution San Antonio Texas
United States Prism Research St. Paul Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary Abnormalities in urinary albumin excretion that may be associated with prior exposure to single or multiple oral doses of BMS-986094 By Day 7 Yes
Secondary 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 Yes
Secondary 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 Yes
Secondary Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094 By Day 30 Yes
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