Clinical trial NCT06493409: A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
Official title: A Phase I, Two-part, Single-center, Open-label, Drug-drug Interaction Study to Assess the Effect of Voriconazole (Part 1) and Quinidine (Part 2) on the Pharmacokinetics of a Single Dose of Repotrectinib (BMS-986472) in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: drug interaction
healthy
repotrectinib
BMS-986472
pharmacokinetics
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

* History of clinically significant acute or chronic medical illness, such as endocrine, gastrointestinal (GI), cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee.
* History of GI disease or surgery that could possibly affect drug absorption, distribution, metabolism, and excretion (ADME) (eg, bariatric procedure, cholecystectomy). Uncomplicated appendectomy and hernia repair are acceptable.
* Gilbert's syndrome.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 23
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 23
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
timeFrame: Up to Day 23
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 52
measure: Number of participants with Severe Adverse Events (SAEs)
timeFrame: Up to Day 52
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 23
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 23
measure: Number of participants with electrocardiogram abnormalities
timeFrame: Up to Day 23
measure: Number of participants with clinical safety laboratory test abnormalities
timeFrame: Up to Day 22
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 23
measure: Apparent terminal phase half-life (T-HALF)
timeFrame: Up to Day 23
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to Day 23
measure: Apparent volume of distribution of terminal phase (Vz/F)
timeFrame: Up to Day 23
measure: Cmax
timeFrame: Up to Day 23
measure: Area under the plasma concentration-time curve over one dosing interval (AUC(TAU))
timeFrame: Up to Day 23
measure: Trough observed plasma concentration (Ctrough)
timeFrame: Up to Day 23
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea - Daytona Beach
state: Florida
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: