Healthy ParticipantsPhase 1NCT04515628
Study to Assess the Effect of Branebrutinib on the Drug Levels of Rosuvastatin in Healthy Participants
A Phase 1 study testing Rosuvastatin and Branebrutinib in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Rosuvastatin and Branebrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2020to 26 Oct 2020
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations by investigator
- Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, as measured at screening visit
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Who cannot join
- Women who are of childbearing potential
- Women who are pregnant or breastfeeding
- Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study, including a history of or active liver disease
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State Branebrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents, rosuvastatin is also a likely concomitant drug for participants who would potentially be treated with branebrutinib.
- Conditions
- Healthy Participants
- Being tested
- Rosuvastatin, Branebrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
Specified dose on specified days
BranebrutinibDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Period A: Rosuvastatin | Experimental | Not described Receives: Drug: Rosuvastatin |
| Period B: Branebrutinib | Experimental | Not described Receives: Drug: Branebrutinib |
| Period C: Branebrutinib + Rosuvastatin and Branebrutinib | Experimental | Not described Receives: Drug: Rosuvastatin; Drug: Branebrutinib |
| Period D: Branebrutinib | Experimental | Not described Receives: Drug: Branebrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of rosuvastatin
Measured: Up to 6 days
Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib
Measured: Day 13
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin
Measured: Up to 6 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib
Measured: Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin
Measured: Up to 6 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin when coadministered with branebrutinib
Measured: Day 13
Secondary outcomes (14)
Incidence of Adverse Events (AEs)
Measured: Up to 33 days
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 77 days
Incidence of AEs leading to discontinuation
Measured: Up to 33 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 54 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 54 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 54 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Measured: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Measured: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Measured: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Measured: Up to 54 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Measured: Up to 53 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Measured: Up to 53 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Measured: Up to 53 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start2 Aug 2020
- Primary completion18 Oct 2020
- Study completion26 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT04515628
- Sponsor's protocol ID
- IM014-032
- Status last verified
- Feb 2022
- First submitted
- 14 Aug 2020
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State Branebrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
- ClinicalTrials.gov ID
- NCT04515628
- Acronym / sponsor ID
- IM014-032
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2020 (actual)
- Primary completion
- 18 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 17 Aug 2020 (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 examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents, rosuvastatin is also a likely concomitant drug for participants who would potentially be treated with branebrutinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Period A: Rosuvastatin | Experimental | Drug: Rosuvastatin |
| Period B: Branebrutinib | Experimental | Drug: Branebrutinib |
| Period C: Branebrutinib + Rosuvastatin and Branebrutinib | Experimental | Drug: Rosuvastatin, Drug: Branebrutinib |
| Period D: Branebrutinib | Experimental | Drug: Branebrutinib |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations by investigator
- Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, as measured at screening visit
- Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Key exclusion criteria (5 listed)
- Women who are of childbearing potential
- Women who are pregnant or breastfeeding
- Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study, including a history of or active liver disease
- Any other sound medical, psychiatric, and/or social reason as determined by the investigator
- 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 |
|---|---|---|
| RosuvastatinSpecified dose on specified days | Drug | Period A: Rosuvastatin, Period C: Branebrutinib + Rosuvastatin and Branebrutinib |
| BranebrutinibSpecified dose on specified days | Drug | Period B: Branebrutinib, Period C: Branebrutinib + Rosuvastatin and Branebrutinib, Period D: Branebrutinib |
Primary outcome
Maximum observed plasma concentration (Cmax) of rosuvastatin
Time frame: Up to 6 days
Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib
Time frame: Day 13
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin
Time frame: Up to 6 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib
Time frame: Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin
Time frame: Up to 6 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin when coadministered with branebrutinib
Time frame: Day 13
14 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 33 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 77 days
Incidence of AEs leading to discontinuation
Time frame: Up to 33 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 54 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 54 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 54 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
Time frame: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Time frame: Up to 54 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
Time frame: Up to 54 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 53 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 53 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 53 days
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 10 Mar 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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 Rosuvastatin and Branebrutinib in people with Healthy Participants, 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 5 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 10 Mar 2022. 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) of rosuvastatin (time frame: Up to 6 days). The study lists 6 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 10 Mar 2022.