Healthy VolunteersPhase 1NCT03341390
An Investigational Study to Assess the Effect of BMS-986177 on Aspirin in Healthy Participants
A Phase 1 study testing Aspirin and BMS-986177 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177 when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of BMS-986177 or placebo, with a once-daily dose of aspirin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Aspirin and BMS-986177
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 16 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
- Signed written consent form.
- Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
- Women participants must have documented proof they are not of childbearing potential.
- Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986177, and for a total of 93 days after the last dose of BMS-986177; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
- Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2.
- Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.
Who cannot join
- Women who are of childbearing potential or breastfeeding.
- Any significant acute or chronic illness.
- History of gastroesophageal reflux disease, dyspepsia, protracted nausea or chronic diarrhea.
- History of upper gastrointestinal ulcer disease within 6 months or current symptomatic or recent gastrointestinal disease that could impact absorption of study treatment.
- Abnormal renal profile and/or hematuria (if male) within 3 months of study start.
- History or evidence of abnormal bleeding and/or coagulation disorder and/or evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation, or a history of spontaneous bleeding.
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- Any major surgery within 4 weeks of study treatment administration or planned within 2 weeks after completion of the study.
- Donation of blood to a blood bank or in a clinical study (except screening or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks for plasma only).
- Blood transfusion within 3 months of study treatment administration.
- Use of tobacco- or nicotine-containing products (including, but not limited to cigarettes, pipes, cigars, e-cigarettes, chewing tobacco, nicotine patches, nicotine lozenges or nicotine gum) within 6 months prior to study treatment administration.
- History of allergy to aspirin or related compounds.
- Other protocol-defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Coadministration of Multiple Doses of BMS-986177 on Aspirin in Healthy Participants
The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177 when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of BMS-986177 or placebo, with a once-daily dose of aspirin. The safety, tolerability and movement of BMS-986177 into, through and out of the body (pharmacokinetics/PK) will be assessed, as will the effect of BMS-986177 on the PK of aspirin.
- Conditions
- Healthy Volunteers
- Being tested
- Aspirin, BMS-986177, Placebo
- Keywords
- Healthy participants, Healthy subjects, Strokes
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic Acid
1 x 325 mg tablet of aspirin administered once daily
BMS-986177Drug
200 mg of BMS-986177 administered twice daily
PlaceboDrug
200 mg of Placebo administered twice daily
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | 325 mg tablet, once daily for 5 days (Day -5 to -1) Receives: Drug: Aspirin |
| BMS-986177 plus aspirin | Experimental | 200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7) Receives: Drug: Aspirin; Drug: BMS-986177 |
| Placebo plus aspirin | Placebo comparator | 200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7) Receives: Drug: Aspirin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation when coadministered BMS-986177 (twice daily) and aspirin (once daily)
Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment
Measured: Up to 10 days
Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily)
Measured by electrocardiogram (ECG)
Measured: Up to 10 days
Number of participants with vital sign abnormalities.
Measured: Up to 10 days
Number of participants with physical examination abnormalities.
Measured: Up to 10 days
Number of participants with clinical laboratory abnormalities.
Measured: Up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start18 Oct 2017
- Primary completion16 Nov 2017
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT03341390
- Sponsor's protocol ID
- CV010-027
- Status last verified
- Jan 2018
- First submitted
- 30 Oct 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Coadministration of Multiple Doses of BMS-986177 on Aspirin in Healthy Participants
- ClinicalTrials.gov ID
- NCT03341390
- Acronym / sponsor ID
- CV010-027
- Conditions
- Healthy Volunteers
- Keywords
- Healthy participants, Healthy subjects, Strokes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 14 Nov 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.
The purpose of this study is to investigate the effect of taking multiple doses of BMS-986177 when aspirin is taken once-daily. Eligible participants will receive twice-daily doses of BMS-986177 or placebo, with a once-daily dose of aspirin. The safety, tolerability and movement of BMS-986177 into, through and out of the body (pharmacokinetics/PK) will be assessed, as will the effect of BMS-986177 on the PK of aspirin.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: Aspirin325 mg tablet, once daily for 5 days (Day -5 to -1) |
| BMS-986177 plus aspirin | Experimental | Drug: Aspirin, Drug: BMS-986177200 mg BMS-986177 twice daily and 325 mg tablet aspirin once daily (Day 1-7) |
| Placebo plus aspirin | Placebo comparator | Drug: Aspirin, Drug: Placebo200 mg Placebo twice daily and 325 mg tablet aspirin once daily (Day 1-7) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed written consent form.
- Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
- Women participants must have documented proof they are not of childbearing potential.
- Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986177, and for a total of 93 days after the last dose of BMS-986177; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
- Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2.
Key exclusion criteria (12 listed)
- Women who are of childbearing potential or breastfeeding.
- Any significant acute or chronic illness.
- History of gastroesophageal reflux disease, dyspepsia, protracted nausea or chronic diarrhea.
- History of upper gastrointestinal ulcer disease within 6 months or current symptomatic or recent gastrointestinal disease that could impact absorption of study treatment.
- Abnormal renal profile and/or hematuria (if male) within 3 months of study start.
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 |
|---|---|---|
| AspirinAlso: Acetylsalicylic Acid1 x 325 mg tablet of aspirin administered once daily | Drug | Aspirin, BMS-986177 plus aspirin, Placebo plus aspirin |
| BMS-986177200 mg of BMS-986177 administered twice daily | Drug | BMS-986177 plus aspirin |
| Placebo200 mg of Placebo administered twice daily | Drug | Placebo plus aspirin |
Primary outcome
Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation when coadministered BMS-986177 (twice daily) and aspirin (once daily)
Time frame: Up to 10 days
Safety and tolerability of multiple doses of BMS-986177 measured by investigator assessment
Number of potential clinically significant changes in electrical activity of the heart in participants coadministered BMS-986177 (twice daily) and aspirin (once daily)
Time frame: Up to 10 days
Measured by electrocardiogram (ECG)
Number of participants with vital sign abnormalities.
Time frame: Up to 10 days
Number of participants with physical examination abnormalities.
Time frame: Up to 10 days
Number of participants with clinical laboratory abnormalities.
Time frame: Up to 10 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 19 Jan 2018.
- 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 Aspirin and BMS-986177 in people with Healthy Volunteers, 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 6 inclusion and 12 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 19 Jan 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. Some participants in this study may receive a placebo. 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?
Number of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation when coadministered BMS-986177 (twice daily) and aspirin (once daily) (time frame: Up to 10 days). The study lists 5 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 19 Jan 2018.