ThrombosisPhase 1NCT03224260
To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
A Phase 1 study testing BMS-986177 in people with Thrombosis, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 7 Nov 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be first-generation Japanese (born in Japan and not living outside of Japan for > 10 years; both parents must be ethnically Japanese)
- Body Mass Index 18.0 to 25.0 kg/m2, inclusive
- Women must not be of nonchildbearing potential (cannot become pregnant)
Who cannot join
- Any significant acute or chronic medical illness
- History of allergy to BMS-986177 or other factor Xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- History or evidence of abnormal bleeding or coagulation disorder
- Other protocol defined inclusion and exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials
Anaheim, California, 90630
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.
- Conditions
- Thrombosis
- Being tested
- BMS-986177, Matched Placebo
- 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
Oral Suspension
Matched PlaceboOther
Oral Suspension
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Receive 50 mg BMS-986177 once daily or placebo Receives: Drug: BMS-986177; Other: Matched Placebo |
| Treatment B | Experimental | Receive 200 mg BMS-986177 once daily or placebo Receives: Drug: BMS-986177; Other: Matched Placebo |
| Treatment C | Experimental | Receive 500 mg BMS-986177 once daily or placebo Receives: Drug: BMS-986177; Other: Matched Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Death
Measured by investigator assessment
Measured: 30 days after last dose
Incidence of Serious Adverse Events (SAEs)
Measured by investigator assessment
Measured: 30 days after last dose
Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy
Measured by investigator assessment
Measured: 17 days
Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding
Measured by investigator assessment
Measured: 17 days
Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature)
Measured by investigator assessment
Measured: 17 days
Change from baseline in electrocardiogram findings (ECGs)
Measured by investigator assessment
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start28 Jun 2017
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 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
- NCT03224260
- Sponsor's protocol ID
- CV010-011
- Status last verified
- May 2018
- First submitted
- 18 Jul 2017
- Last updated
- 1 Jun 2018
- 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 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
- ClinicalTrials.gov ID
- NCT03224260
- Acronym / sponsor ID
- CV010-011
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 21 Jul 2017 (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.
Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: BMS-986177, Other: Matched PlaceboReceive 50 mg BMS-986177 once daily or placebo |
| Treatment B | Experimental | Drug: BMS-986177, Other: Matched PlaceboReceive 200 mg BMS-986177 once daily or placebo |
| Treatment C | Experimental | Drug: BMS-986177, Other: Matched PlaceboReceive 500 mg BMS-986177 once daily or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be first-generation Japanese (born in Japan and not living outside of Japan for > 10 years; both parents must be ethnically Japanese)
- Body Mass Index 18.0 to 25.0 kg/m2, inclusive
- Women must not be of nonchildbearing potential (cannot become pregnant)
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness
- History of allergy to BMS-986177 or other factor Xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- History or evidence of abnormal bleeding or coagulation disorder
- Other protocol defined inclusion and 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 |
|---|---|---|
| BMS-986177Oral Suspension | Drug | Treatment A, Treatment B, Treatment C |
| Matched PlaceboOral Suspension | Other | Treatment A, Treatment B, Treatment C |
Primary outcome
Occurrence of Death
Time frame: 30 days after last dose
Measured by investigator assessment
Incidence of Serious Adverse Events (SAEs)
Time frame: 30 days after last dose
Measured by investigator assessment
Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy
Time frame: 17 days
Measured by investigator assessment
Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding
Time frame: 17 days
Measured by investigator assessment
Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature)
Time frame: 17 days
Measured by investigator assessment
Change from baseline in electrocardiogram findings (ECGs)
Time frame: 17 days
Measured by investigator assessment
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 1 Jun 2018.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS clinical trial educational resourceLink 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 BMS-986177 in people with Thrombosis, 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 1 Jun 2018. 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?
Occurrence of Death (time frame: 30 days after last dose). 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 1 Jun 2018.