ThrombosisPhase 1NCT02959060
A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects
A Phase 1 study testing BMS-986177 and Rifampin in people with Thrombosis, run by Bristol-Myers Squibb.
Trial summary
This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- BMS-986177 and Rifampin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2016
- 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
- Signed Informed Consent
- Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
- Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function.
- Women participants must have documented proof that they are not of childbearing potential.
- Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.
Who cannot join
- Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert
- History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.
- Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
- History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds
About this study
Official title: An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects
This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)
- Conditions
- Thrombosis
- Being tested
- BMS-986177, Rifampin
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986177Drug
Single dose of BMS-986177 and multiple doses of Rifampin
RifampinDrug
Single dose of BMS-986177 and multiple doses of Rifampin
| Study group | Role | What they receive |
|---|---|---|
| BMS-986177 and Rifampin | Experimental | Not described Receives: Drug: BMS-986177; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Days1-15
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Days1-15
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Measured: Days1-15
Secondary outcomes (1)
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death
Measured: Screening- until 30 days after discontinuation of dosing or subject's participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT02959060
- Sponsor's protocol ID
- CV010-014
- Status last verified
- Jan 2017
- First submitted
- 7 Nov 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Perera V, Wang Z, Lubin S, Christopher LJ, Chen W, Xu S, Seiffert D, DeSouza M, Murthy B. Effects of rifampin on the pharmacokinetics and pharmacodynamics of milvexian, a potent, selective, oral small molecule factor XIa inhibitor. Sci Rep. 2022 Dec 23;12(1):22239. doi: 10.1038/s41598-022-25936-2.
PubMed 36564395
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986177 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02959060
- Acronym / sponsor ID
- CV010-014
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Nov 2016 (estimated)
- 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.
This study is to evaluate the effect of rifampin on the single-dose pharmacokinetics (PK) of BMS-986177 in healthy participants with parameters like Cmax, AUC(INF), AUC(0-T)
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986177 and Rifampin | Experimental | Drug: BMS-986177, Drug: Rifampin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed Informed Consent
- Healthy men and women (not of child bearing potential) as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests including coagulation parameters.
- Subjects with body mass index of 18 to 30 kg/m2, inclusive and with normal kidney function.
- Women participants must have documented proof that they are not of childbearing potential.
- Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-986177 plus 5 half-lives (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days after completion of BMS-986177 treatment.
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness, including any other condition listed as a contraindication in the rifampin package insert
- History of recurrent headaches, dizziness, chronic diarrhea, gastroesophageal reflux disease, dyspepsia, gastrointestinal ulcer disease, recurrent urinary tract infections, hypermenorrhea and recurrent candida infections, abnormal bleeding, history of hemophilia, Rosenthal syndrome, FXIa deficiency, or other coagulopathies.
- Recent surgery, head injury, blood transfusion, systemic lupus erythamatous, aneurysm, drug or alcohol abuse and use of tobacco or nicotine containing products in past six months.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations beyond what is consistent with the target population
- History of allergy to BMS-986177, FXIa inhibitors , rifampin or related compounds
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 |
|---|---|---|
| BMS-986177Single dose of BMS-986177 and multiple doses of Rifampin | Drug | BMS-986177 and Rifampin |
| RifampinSingle dose of BMS-986177 and multiple doses of Rifampin | Drug | BMS-986177 and Rifampin |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Days1-15
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Days1-15
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Time frame: Days1-15
1 secondary outcome
Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), AEs leading to discontinuation, and death
Time frame: Screening- until 30 days after discontinuation of dosing or subject's participation
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 6 Jan 2017.
- Derived from this study: PubMed 36564395Perera V, Wang Z, Lubin S, Christopher LJ, Chen W, Xu S, Seiffert D, DeSouza M, Murthy B. Effects of rifampin on the pharmacokinetics and pharmacodynamics of milvexian, a potent, selective, oral small molecule factor XIa inhibitor. Sci Rep. 2022 Dec 23;12(1):22239. doi: 10.1038/s41598-022-25936-2.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986177 and Rifampin in people with Thrombosis, run by Bristol-Myers Squibb.
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 5 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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: Days1-15). 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?
On the ClinicalTrials.gov record for NCT02959060, which also lists 1 linked publication.
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 6 Jan 2017.