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

August 13, 2014 updated by: Bristol-Myers Squibb
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

113

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution
  • United States
    • California
      • Los Angeles, California, United States, 90036
        • Local Institution
    • Minnesota
      • St. Paul, Minnesota, United States, 55114
        • Prism Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • New Orleans Center For Clinical Research - Knoxville
    • Texas
      • San Antonio, Texas, United States, 78215
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: BMS-986094/INX-08189
Other Names:
  • Observational study - No Intervention subjects were previously treated with BMS-986094/INX-08189
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
Drug: Placebo matching BMS-986094/INX-08189
Other Names:
  • Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Up to Day 90
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
Time Frame: Up to Day 90
Up to Day 90

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: Baseline (pre-dose Day 1 ECG from parent study) and By Day 30
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
Time Frame: By Day 90
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
Time Frame: By Day 30
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
Time Frame: Baseline (Day 1 from parent study) and By Day 14
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
Time Frame: By Day 7
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
Time Frame: By Day 90
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
Time Frame: By Day 30
By Day 30
Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094
Time Frame: By Day 30
By Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 20, 2012

First Submitted That Met QC Criteria

November 23, 2012

First Posted (Estimate)

November 26, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 13, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI472-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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