A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Repotrectinib in Healthy Participants and Those With Moderate and Severe Hepatic Impairment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352528
• Other study ID #: CA127-1070
• Status: Recruiting
• Phase: Phase 1
• Start date: April 29, 2024
• Est. completion date: July 24, 2025

Study information

• Verified date: June 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact http://www.bmsstudyconnect.com/
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 24, 2025
• Est. primary completion date: July 24, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Repotrectinib
Specified dose on specified days

Locations

Country	Name	City	State
United States	Local Institution - 0006	Miami Lakes	Florida
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Local Institution - 0005	Orlando	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Local Institution - 0004	San Antonio	Texas
United States	Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Days 1 to 11
Primary	Time of maximum observed plasma concentration (Tmax)		Days 1 to 11
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))		Days 1 to 11
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))		Days 1 to 11
Secondary	Number of participants with Adverse Events (AEs)		Up to 28 days following last dose
Secondary	Number of participants with Severe Adverse Events (SAEs)		Up to 28 days following last dose
Secondary	Number of participants with physical examination abnormalities		Up to Day 11
Secondary	Number of participants with vital sign abnormalities		Up to Day 11
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to Day 11
Secondary	Number of participants with clinical safety laboratory test abnormalities		Up to Day 11

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting