Healthy ParticipantsPhase 1NCT04124003
A Study to Assess the Drug-drug Interaction of BMS-963272 and Rosuvastatin
A Phase 1 study testing rosuvastatin and BMS-963272 in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy 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 Participants
- What is being tested?
- rosuvastatin and BMS-963272
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2019to 3 Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Women must not be of childbearing potential (WNOCBP)
- Women and men must agree to follow instructions for methods of contraception
Who cannot join
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study.
- Any major surgery within 4 weeks of study drug administration
- Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration
- Previous treatment with BMS-963272
- Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1
- Other protocol-defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
United States1 site
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, 84124
About this study
Official title: An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants
Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants
- Conditions
- Healthy Participants
- Being tested
- rosuvastatin, BMS-963272
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
BMS-963272Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| rosuvastatin + BMS-963272 | Experimental | Not described Receives: Drug: rosuvastatin; Drug: BMS-963272 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax)
Measured: up to Day 10
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T)
Measured: up to Day 10
Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)
Measured: up to Day 10
Secondary outcomes (10)
Incidence of Adverse Events (AEs)
Measured: Approximately 50 days
Number of significant changes in lab assessments of blood serum
Measured: Approximately 50 days
Number of significant changes in lab assessments of blood
Measured: Approximately 50 days
Number of significant changes in lab assessments of urine
Measured: Approximately 50 days
Blood pressure
Measured: Approximately 50 days
Body temperature
Measured: Approximately 50 days
Respiratory rate
Measured: Approximately 50 days
Number of Participants with abnormal physical examination findings
Measured: Approximately 50 days
Heart rate
Measured: Approximately 50 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Measured: Approximately 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start8 Oct 2019
- Primary completion3 Jan 2020
- Study completion3 Jan 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124003
- Sponsor's protocol ID
- MB006-018
- Status last verified
- Mar 2020
- First submitted
- 9 Oct 2019
- Last updated
- 10 Mar 2020
- 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 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-sequence, Drug-drug Interaction Study to Assess the Effect of BMS-963272 Coadministration on the Systemic Exposure of Rosuvastatin in Healthy Participants
- ClinicalTrials.gov ID
- NCT04124003
- Acronym / sponsor ID
- MB006-018
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 3 Jan 2020 (actual)
- First posted
- 11 Oct 2019 (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.
Phase 1 study that assesses the effect of BMS-963272 on exposure of rosuvastatin in healthy participants
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rosuvastatin + BMS-963272 | Experimental | Drug: rosuvastatin, Drug: BMS-963272 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Women must not be of childbearing potential (WNOCBP)
- Women and men must agree to follow instructions for methods of contraception
Key exclusion criteria (6 listed)
- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study.
- Any major surgery within 4 weeks of study drug administration
- Any blood transfusion or donation of blood to a blood bank or in a clinical study within 4 weeks of study drug administration
- Previous treatment with BMS-963272
- Participants who smoke, as well as, those who have stopped smoking less than 6 months prior to day 1
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 | rosuvastatin + BMS-963272 |
| BMS-963272Specified dose on specified days | Drug | rosuvastatin + BMS-963272 |
Primary outcome
Maximum concentration (Cmax)
Time frame: up to Day 10
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration AUC(0-T)
Time frame: up to Day 10
Area under the plasma concentration-time curve extrapolated to infinity AUC (INF)
Time frame: up to Day 10
10 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Approximately 50 days
Number of significant changes in lab assessments of blood serum
Time frame: Approximately 50 days
Number of significant changes in lab assessments of blood
Time frame: Approximately 50 days
Number of significant changes in lab assessments of urine
Time frame: Approximately 50 days
Blood pressure
Time frame: Approximately 50 days
Body temperature
Time frame: Approximately 50 days
Respiratory rate
Time frame: Approximately 50 days
Number of Participants with abnormal physical examination findings
Time frame: Approximately 50 days
Heart rate
Time frame: Approximately 50 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
Time frame: Approximately 50 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 2020.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink 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.
The record lists no contact. Use the official record to reach the sponsor.
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 BMS-963272 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 6 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 2020. 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 concentration (Cmax) (time frame: up to Day 10). 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 10 Mar 2020.