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

This study is currently recruiting participants.
Verified August 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01732848
First received: November 20, 2012
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention
Healthy
Hepatitis C
Drug: BMS-986094/INX-08189
Drug: Placebo matching BMS-986094/INX-08189

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Abnormalities in troponin levels that may be associated with prior exposure to single or multiple doses of BMS-986094 [ Time Frame: By Day 30 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 204
Study Start Date: November 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732848

Contacts
Contact: For participation information at a USA site use a phone number below. For Site information outside USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

Locations
United States, California
Axis Clinical Trials Recruiting
Los Angeles, California, United States, 90036
Contact: Lydie L Hazan, Site 0002    310-289-8242      
United States, Minnesota
Prism Research Recruiting
St. Paul, Minnesota, United States, 55114
Contact: Mark A Matson, Site 0003    651-641-2900      
United States, Tennessee
New Orleans Center For Clinical Research - Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Contact: William Smith, Site 0005    865-544-9100      
United States, Texas
Alamo Medical Research Recruiting
San Antonio, Texas, United States, 78215
Contact: Eric Lawitz, Site 0004    210-253-3426      
Puerto Rico
Local Institution Recruiting
San Juan, Puerto Rico, 00927
Contact: Site 0001         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01732848     History of Changes
Other Study ID Numbers: AI472-013
Study First Received: November 20, 2012
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Bristol-Myers Squibb:
Volunteers

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 23, 2014