Healthy VolunteersPhase 1NCT06493409
A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants
A Phase 1 study testing Repotrectinib, Voriconazole and Quinidine in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Repotrectinib, Voriconazole and Quinidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 7 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea - Daytona Beach
Daytona Beach, Florida, 32117
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- Repotrectinib, Voriconazole, Quinidine
- Keywords
- drug interaction, healthy, repotrectinib, BMS-986472, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepotrectinibDrug
Also called BMS-986472
Specified dose on specified days
VoriconazoleDrug
Specified dose on specified days
QuinidineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | Not described Receives: Drug: Repotrectinib; Drug: Voriconazole |
| Part 2 | Experimental | Not described Receives: Drug: Repotrectinib; Drug: Quinidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to Day 23
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to Day 23
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to Day 23
Secondary outcomes (13)
Number of participants with Adverse Events (AEs)
Measured: Up to Day 52
Number of participants with Severe Adverse Events (SAEs)
Measured: Up to Day 52
Number of participants with physical examination abnormalities
Measured: Up to Day 23
Number of participants with vital sign abnormalities
Measured: Up to Day 23
Number of participants with electrocardiogram abnormalities
Measured: Up to Day 23
Number of participants with clinical safety laboratory test abnormalities
Measured: Up to Day 22
Time of maximum observed plasma concentration (Tmax)
Measured: Up to Day 23
Apparent terminal phase half-life (T-HALF)
Measured: Up to Day 23
Apparent total body clearance (CLT/F)
Measured: Up to Day 23
Apparent volume of distribution of terminal phase (Vz/F)
Measured: Up to Day 23
Cmax
Measured: Up to Day 23
Area under the plasma concentration-time curve over one dosing interval (AUC(TAU))
Measured: Up to Day 23
Trough observed plasma concentration (Ctrough)
Measured: Up to Day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start26 Aug 2024
- Primary completion7 Dec 2024
- Study completion7 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06493409
- Sponsor's protocol ID
- CA127-1072
- Status last verified
- Aug 2025
- First submitted
- 25 Jun 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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/disclosurecommitment.html
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06493409
- Acronym / sponsor ID
- CA127-1072
- Conditions
- Healthy Volunteers
- Keywords
- drug interaction, healthy, repotrectinib, BMS-986472, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 7 Dec 2024 (actual)
- Study completion
- 7 Dec 2024 (actual)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Repotrectinib, Drug: Voriconazole |
| Part 2 | Experimental | Drug: Repotrectinib, Drug: Quinidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RepotrectinibAlso: BMS-986472Specified dose on specified days | Drug | Part 1, Part 2 |
| VoriconazoleSpecified dose on specified days | Drug | Part 1 |
| QuinidineSpecified dose on specified days | Drug | Part 2 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 23
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to Day 23
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to Day 23
13 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 52
Number of participants with Severe Adverse Events (SAEs)
Time frame: Up to Day 52
Number of participants with physical examination abnormalities
Time frame: Up to Day 23
Number of participants with vital sign abnormalities
Time frame: Up to Day 23
Number of participants with electrocardiogram abnormalities
Time frame: Up to Day 23
Number of participants with clinical safety laboratory test abnormalities
Time frame: Up to Day 22
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 23
Apparent terminal phase half-life (T-HALF)
Time frame: Up to Day 23
Apparent total body clearance (CLT/F)
Time frame: Up to Day 23
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to Day 23
Cmax
Time frame: Up to Day 23
Area under the plasma concentration-time curve over one dosing interval (AUC(TAU))
Time frame: Up to Day 23
Trough observed plasma concentration (Ctrough)
Time frame: Up to Day 23
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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/disclosurecommitment.html
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Repotrectinib, Voriconazole and Quinidine in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Up to Day 23). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.