Moderate Liver Impairment Clinical Trial
Official title:
An Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 in Participants With Normal Hepatic Function and Participants With Moderate and Severe Hepatic Impairment
| Verified date | June 2022 |
| Source | Bristol-Myers Squibb |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | June 2, 2022 |
| Est. primary completion date | June 2, 2022 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 21 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations - Body mass index (BMI) of 18.0 kg/m^2 to 40.0 kg/m^2, inclusive. BMI = weight (kg)/height (m^2) Exclusion Criteria: - Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status - History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease Other protocol-defined inclusion/exclusion criteria apply |
| Country | Name | City | State |
|---|---|---|---|
| United States | Local Institution - 0002 | Miami | Florida |
| United States | Local Institution | Orlando | Florida |
| United States | Local Institution - 0001 | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed plasma concentration (Cmax) | Up to 29 days | ||
| Primary | Time of maximum observed plasma concentration (Tmax) | Up to 29 days | ||
| Primary | Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) | Up to 29 days | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 31 days | ||
| Secondary | Number of participants with clinical laboratory abnormalities | Up to 31 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 31 days | ||
| Secondary | Number of participants with electrocardiogram (ECG) abnormalities | Up to 31 days | ||
| Secondary | Number of participants with physical examination abnormalities | Up to 31 days | ||
| Secondary | Maximum observed plasma concentration (Cmax) | Up to 29 days | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | Up to 29 days | ||
| Secondary | Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T)) | Up to 29 days |