32 Participants Needed

Voriconazole and Quinidine with Repotrectinib for Healthy Subjects

Recruiting at 1 trial location
BC
Fl
Overseen ByFirst line of email MUST contain NCT # and Site #.
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effects of coadministration of voriconazole or quinidine on the pharmacokinetics (PK) of repotrectinib in healthy male and female (individual not of childbearing potential \[INOCBP\]) participants.

Research Team

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for healthy adult men and women who cannot become pregnant. Participants must not have any significant health issues that could interfere with the study or be taking medications that might interact with the drugs being tested.

Inclusion Criteria

Healthy male and female individual(s) not of childbearing potential (INOCBP) participants of any race or ethnicity, as determined by no clinically significant findings in medical history, physical examination, 12-lead ECG, or vital signs as determined by the investigator or designee
Potassium, magnesium, and calcium at or above the lower limit of normal. For other clinical laboratory parameters, no clinically significant findings as determined by the investigator or designee
Must have a body mass index between 18 and 30 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF

Exclusion Criteria

I do not have any serious long-term health conditions.
I have had GI surgery that may affect how drugs work in my body, except for simple appendix or hernia operations.
Other protocol-defined Inclusion/Exclusion criteria apply
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive a single dose of repotrectinib with voriconazole to assess pharmacokinetics

1 week

Treatment Part 2

Participants receive a single dose of repotrectinib with quinidine to assess pharmacokinetics

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Quinidine
  • Voriconazole
Trial Overview The study is testing how repotrectinib, a medication, behaves in the body when taken with either voriconazole or quinidine. It's to see if these other drugs change how much repotrectinib gets into the bloodstream and how long it stays there.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment2 Interventions
Group II: Part 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

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