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Healthy VolunteersPhase 1NCT03698513

A Study to Assess Administration of an Oral Anti-thrombotic With Antiplatelet Therapy in Healthy Subjects

A Phase 1 study testing BMS-986177, Clopidogrel and Aspirin in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel 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?
BMS-986177, Clopidogrel and Aspirin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
113 participants
Where
1 siteUnited States
Study dates
4 Oct 2018to 19 Feb 2019
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

  • Must have a Body Mass Index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
  • Must have a normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) of > 80 mL/min/1.73 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in the urine
  • For Parts 1 and 2:
  • Must be a clopidogrel responder (eg, a decrease in platelet aggregation of at least 30% after a single 600-mg dose of clopidogrel compared with baseline).

Who cannot join

  • Any significant acute or chronic medical illness, including tinnitus or any other condition listed as a contraindication in the aspirin package insert.
  • History of dizziness and/or recurrent headaches (i.e. daily headaches lasting for 1 week's duration in the last month prior to study treatment administration).
  • History of head injury in the last 2 years, including participants with base skull fractures, intracranial tumor, or aneurysm.
  • History of gastroesophageal reflux disease, dyspepsia (indigestion), protracted nausea, or chronic diarrhea (defined as 3 or 4 loose stools per day that last for ≥ 4 weeks) within the past 6 months.
  • Other protocol-defined inclusion/exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • PPD Development, LP

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Randomized, Cross-over Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986177 (an Oral Antithrombotic) With Single and Dual Antiplatelet Therapy (Aspirin and Clopidogrel) in Healthy Participants

This study will investigate the safety and interaction of BMS-986177 in healthy volunteers, when administered with Aspirin and/or Clopidogrel

Being tested
BMS-986177, Placebo (for BMS-986177), Clopidogrel, Aspirin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986177Drug

    BMS-986177 capsule

  • Placebo (for BMS-986177)Other

    BMS-986177 placebo match capsule

  • ClopidogrelDrug

    Clopidogrel tablet

  • AspirinDrug

    Aspirin tablet

Study groups in NCT03698513
Study groupRoleWhat they receive
BMS-986177 + Aspirin + Clopidogrel (Part 1)ExperimentalBMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
Receives: Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin
BMS-986177 (Part 1)ExperimentalBMS-986177 200 mg capsule twice daily (days 1-5)
Receives: Drug: BMS-986177
BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)Placebo comparatorBMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5) + Clopidogrel 300 mg once daily (day 1) then 75 mg tablet once daily (days 2-5)
Receives: Other: Placebo (for BMS-986177); Drug: Clopidogrel; Drug: Aspirin
BMS-986177 (Part 2)ExperimentalBMS-986177 200 mg capsule twice daily (days 1-5)
Receives: Drug: BMS-986177
BMS-986177 placebo + Clopidogrel (Part 2)Placebo comparatorBMS-986177 placebo match capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
Receives: Other: Placebo (for BMS-986177); Drug: Clopidogrel
BMS-986177 + Clopidogrel (Part 2)ExperimentalBMS-986177 200 mg capsule twice daily (days 1-5) + Clopidogrel 300 mg tablet once daily (day 1) then 75 mg tablet once daily (days 2-5)
Receives: Drug: BMS-986177; Drug: Clopidogrel
BMS-986177 (Part 3)ExperimentalBMS-986177 200 mg capsule twice daily (days 1-5)
Receives: Drug: BMS-986177
BMS-986177 placebo + Aspirin (Part 3)Placebo comparatorBMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
Receives: Other: Placebo (for BMS-986177); Drug: Aspirin
BMS-986177 + Aspirin (Part 3)ExperimentalBMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)
Receives: Drug: BMS-986177; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events (AEs)

    Measured: Up to Day 33

  2. Incidence of Serious Adverse Events (SAEs)

    Measured: Up to Day 95

  3. Incidence of Adverse Events (AEs) leading to discontinuation

    Measured: Up to Day 33

  4. Number of participants with vital sign abnormalities

    Measured: Up to Day 33

  5. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Measured: Up to Day 33

  6. Number of participants with clinical laboratory abnormalities

    Measured: Up to Day 33

  7. Number of participants with physical examination abnormalities

    Measured: Up to Day 33

Secondary outcomes (7)

  1. Maximum observed plasma concentration (Cmax)

    Cmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

    Measured: Up to Day 33

  2. Area under the plasma concentration time curve in one dosing interval [AUC(TAU)]

    AUC(TAU) of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

    Measured: Up to Day 33

  3. Time of maximum observed concentration (Tmax)

    Tmax of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

    Measured: Up to Day 33

  4. Terminal plasma half-life (T-HALF)

    T-Half of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

    Measured: Up to Day 33

  5. Trough observed plasma concentration (Ctrough)

    Ctrough of BMS-986177, acetylsalicylic acid, salicylic acid, clopidogrel and clopidogrel metabolite

    Measured: Up to Day 26

  6. Apparent total body clearance (CLT/F)

    CLT/F of BMS-986177, aspirin, clopidogrel

    Measured: Up to Day 33

  7. Volume of distribution (Vz/F)

    Vz/F of BMS-986177, aspirin, clopidogrel

    Measured: Up to Day 33

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start4 Oct 2018
  3. Primary completion19 Feb 2019
  4. Study completion19 Feb 2019

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03698513
Sponsor's protocol ID
CV010-034
Status last verified
Sep 2021
First submitted
4 Oct 2018
Last updated
29 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Perera V, Abelian G, Luettgen J, Aronson R, Li D, Wang Z, Zhang L, Lubin S, Merali S, Murthy B. Safety, tolerability, pharmacokinetics and pharmacodynamics of milvexian with aspirin and/or clopidogrel in healthy participants. Sci Rep. 2024 Jul 18;14(1):16591. doi: 10.1038/s41598-024-67182-8.

    PubMed 39025971

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-986177, Clopidogrel and Aspirin 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 4 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 29 Sep 2021. 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?

Incidence of Adverse Events (AEs) (time frame: Up to Day 33). The study lists 7 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 NCT03698513, 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 29 Sep 2021.

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