Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Moderate Hepatic Impairment | Experimental |
| |
| Group 2: Severe Hepatic Impairment | Experimental |
| |
| Group 3: Normal Hepatic Function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repotrectinib | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) | Days 1 to 11 | |
| Time of maximum observed plasma concentration (Tmax) | Days 1 to 11 | |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Days 1 to 11 | |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) | Days 1 to 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events (AEs) | Up to 28 days following last dose | |
| Number of participants with Severe Adverse Events (SAEs) | Up to 28 days following last dose | |
Not provided
Inclusion Criteria:
- Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.
i) Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.
ii) Must have a body mass index between 18 and 40 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.
- Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group 1 and Group 2):.
i) Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
ii) Participants have moderate (Group 1), or severe (Group 2) HI as defined by Child-Pugh score.
- Inclusion Criteria for a Matched Healthy Participant (Group 3):.
i) Participant must be free of any clinically significant disease that would interfere with the study evaluations.
ii) Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
iii) Participant must be in good health as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (eg, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the investigator.
Exclusion Criteria:
- Exclusion Criteria for all Participants (Group 1, Group 2, and Group 3):.
i) Any major surgery within 4 weeks of the study intervention administration.
ii) History of drug abuse within 1 year of study intervention administration.
iii) History of alcohol abuse within 1 year of study intervention administration.
iv) Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Panax Clinical Research | Miami Lakes | Florida | 33014-2811 | United States | ||
| Orlando Clinical Research Center |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer 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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Number of participants with physical examination abnormalities |
| Up to Day 11 |
| Number of participants with vital sign abnormalities | Up to Day 11 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 11 |
| Number of participants with clinical safety laboratory test abnormalities | Up to Day 11 |
| Orlando |
| Florida |
| 32809-3017 |
| United States |
| The Texas Liver Institute, Inc. | San Antonio | Texas | 78215 | United States |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000708510 | repotrectinib |
Not provided
Not provided
Not provided