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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014