Repotrectinib
DrugSpecified dose on specified days
Other names: BMS-986472
NCT Number: NCT06352528
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1
Panax Clinical Research, Miami Lakes, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
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.
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
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.
Specified dose on specified days
Other names: BMS-986472
Time frame: Days 1 to 11
Time frame: Days 1 to 11
Time frame: Days 1 to 11
Time frame: Days 1 to 11
Time frame: Up to 28 days following last dose
Time frame: Up to 28 days following last dose
Time frame: Up to Day 11
Time frame: Up to Day 11
Time frame: Up to Day 11
Time frame: Up to Day 11
Bristol-Myers Squibb
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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