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 April 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01732848
First received: November 20, 2012
Last updated: April 17, 2013
Last verified: April 2013
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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: | July 2013 |
| Estimated Primary Completion Date: | July 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:
- Received at least 1 dose of INX-08189 or
- 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 | |
| Local Institution | Not yet recruiting |
| Los Angeles, California, United States, 90036 | |
| Contact: , Site 0002 | |
| United States, Minnesota | |
| Prism Research | Recruiting |
| St. Paul, Minnesota, United States, 55114 | |
| Contact: Mark A Matson, Site 0003 651-641-2900 | |
| United States, Tennessee | |
| Local Institution | Not yet recruiting |
| Knoxville, Tennessee, United States, 37920 | |
| Contact: , Site 0005 | |
| United States, Texas | |
| Local Institution | Not yet recruiting |
| San Antonio, Texas, United States, 78215 | |
| Contact: , Site 0004 | |
| Puerto Rico | |
| Local Institution | Not yet 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: | April 17, 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 June 18, 2013