Atherothrombotic DiseasesPhase 1NCT02957448
A Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects
A Phase 1 study testing BMS 986141 and Rifampin in people with Atherothrombotic Diseases, run by Bristol-Myers Squibb.
Trial summary
This study is to evaluate the effect of multiple doses of rifampin on the single-dose PK of BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h) Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherothrombotic Diseases
- What is being tested?
- BMS 986141 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 Jan 2017
- 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
- 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 32 kg/m2, inclusive.
- 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 plus 5 half-lives of Rifampin (1 day) plus 90 days for a total of 91 days post-treatment completion.
Who cannot join
- Acute or chronic medical illness, subjects with bleeding diathesis, gastroesophageal reflux disease, gastrointestinal ulcer, hepatic disease,coagulation disorder,dyspepsia and being reliant on contact lenses for vision for the duration of study treatment and for 2 days after discontinuation of study treatment (eyeglasses are allowed).
- History of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, periodontal disease, hemorrhoids with rectal bleeding and recent blood donation.
- Prior exposure to BMS-986141 or prothrombin complex, any investigational product or placebo within 4 weeks of study treatment start, any prescription or over the counter drugs except those cleared by BMS clinical monitor.
- History of hypersensitivity to BMS 986141, rifampin, any rifamycins or related compounds, or any component of the formulations
- 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
About this study
Official title: An Open-Label, Single-Sequence Study to Evaluate the Effect of Rifampin on the Single-dose Pharmacokinetics of BMS-986141 in Healthy Subjects
This study is to evaluate the effect of multiple doses of rifampin on the single-dose PK of BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h)
- Conditions
- Atherothrombotic Diseases
- Being tested
- BMS 986141, Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS 986141Drug
Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
RifampinDrug
Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
| Study group | Role | What they receive |
|---|---|---|
| BMS 986141 and Rifampin | Experimental | Not described Receives: Drug: BMS 986141; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-986141
Measured: Days 1-22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
Measured: Days 1-22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
Measured: Days 1-22
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
Measured: Days 1-22
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 posted7 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherothrombotic DiseasesStudies 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
- NCT02957448
- Sponsor's protocol ID
- CV006-029
- Status last verified
- Feb 2017
- First submitted
- 3 Nov 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 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-986141 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02957448
- Acronym / sponsor ID
- CV006-029
- Conditions
- Atherothrombotic Diseases
- 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
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 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 multiple doses of rifampin on the single-dose PK of BMS 986141 with parameters like Cmax, AUC(INF), AUC(0-T), AUC(0-144h)
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 986141 and Rifampin | Experimental | Drug: BMS 986141, Drug: Rifampin |
Who may qualify
- Ages
- 18 to 50 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 32 kg/m2, inclusive.
- 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 plus 5 half-lives of Rifampin (1 day) plus 90 days for a total of 91 days post-treatment completion.
Key exclusion criteria (5 listed)
- Acute or chronic medical illness, subjects with bleeding diathesis, gastroesophageal reflux disease, gastrointestinal ulcer, hepatic disease,coagulation disorder,dyspepsia and being reliant on contact lenses for vision for the duration of study treatment and for 2 days after discontinuation of study treatment (eyeglasses are allowed).
- History of nausea, diarrhoea, recent surgery, use of tobacco or nicotine containing products, drug or alcohol use, periodontal disease, hemorrhoids with rectal bleeding and recent blood donation.
- Prior exposure to BMS-986141 or prothrombin complex, any investigational product or placebo within 4 weeks of study treatment start, any prescription or over the counter drugs except those cleared by BMS clinical monitor.
- History of hypersensitivity to BMS 986141, rifampin, any rifamycins or related compounds, or any component of the formulations
- 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
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 986141Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22) | Drug | BMS 986141 and Rifampin |
| RifampinTwo single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22) | Drug | BMS 986141 and Rifampin |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-986141
Time frame: Days 1-22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141
Time frame: Days 1-22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141
Time frame: Days 1-22
Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141
Time frame: Days 1-22
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 23 Feb 2017.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 986141 and Rifampin in people with Atherothrombotic Diseases, 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 23 Feb 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) of BMS-986141 (time frame: Days 1-22). The study lists 4 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 23 Feb 2017.