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The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Mild Hepatic Impairment |
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| Arm B | Experimental | Moderate Hepatic Impairment |
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| Arm C | Experimental | Matched participants with normal hepatic function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986435 | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration (Cmax) | Up to Day 45 | |
| Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) | Up to Day 45 | |
| Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF) | Up to Day 45 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to Day 45 | |
| Number of participants with serious adverse events (SAEs) | Up to Day 45 | |
| Time of maximum observed concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain the NCT# and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Trials | Recruiting | Chandler | Arizona | 85225 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.
Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See Plan Description
See Plan Description
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| Up to Day 45 |
| Half-life (T-HALF) | Up to Day 45 |
| Apparent total body clearance (CLT/F) | Up to Day 45 |
| Apparent volume of distribution at terminal phase (Vz/F) | Up to Day 45 |
| Panax Clinical Research | Recruiting | Miami Lakes | Florida | 33014 | United States |
|
| Texas Liver Institute | Recruiting | San Antonio | Texas | 78215 | United States |
|