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

NCT03698513 | Completed Phase 1 FDA Drug

• 1 other identifier: CV010-034
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• Incidence of Adverse Events (AEs)

  Up to Day 33

• Incidence of Serious Adverse Events (SAEs)

  Up to Day 95

• Incidence of Adverse Events (AEs) leading to discontinuation

  Up to Day 33

• Number of participants with vital sign abnormalities

  Up to Day 33

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

  Up to Day 33

• Number of participants with clinical laboratory abnormalities

  Up to Day 33

• Number of participants with physical examination abnormalities

  Up to Day 33

Secondary Outcomes (7)

• Maximum observed plasma concentration (Cmax)

  Up to Day 33

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

  Up to Day 33

• Time of maximum observed concentration (Tmax)

  Up to Day 33

• Terminal plasma half-life (T-HALF)

  Up to Day 33

• Trough observed plasma concentration (Ctrough)

  Up to Day 26

Study Arms (9)

BMS-986177 + Aspirin + Clopidogrel (Part 1)

EXPERIMENTAL

BMS-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)

Drug: BMS-986177; Drug: Clopidogrel; Drug: Aspirin

BMS-986177 (Part 1)

EXPERIMENTAL

BMS-986177 200 mg capsule twice daily (days 1-5)

Drug: BMS-986177

BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)

PLACEBO COMPARATOR

BMS-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)

Other: Placebo (for BMS-986177); Drug: Clopidogrel; Drug: Aspirin

BMS-986177 (Part 2)

EXPERIMENTAL

BMS-986177 200 mg capsule twice daily (days 1-5)

Drug: BMS-986177

BMS-986177 placebo + Clopidogrel (Part 2)

PLACEBO COMPARATOR

BMS-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)

Other: Placebo (for BMS-986177); Drug: Clopidogrel

BMS-986177 + Clopidogrel (Part 2)

EXPERIMENTAL

BMS-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)

Drug: BMS-986177; Drug: Clopidogrel

BMS-986177 (Part 3)

EXPERIMENTAL

BMS-986177 200 mg capsule twice daily (days 1-5)

Drug: BMS-986177

BMS-986177 placebo + Aspirin (Part 3)

PLACEBO COMPARATOR

BMS-986177 placebo match capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)

Other: Placebo (for BMS-986177); Drug: Aspirin

BMS-986177 + Aspirin (Part 3)

EXPERIMENTAL

BMS-986177 200 mg capsule twice daily (days 1-5) + Aspirin 325 mg tablet once daily (days 1-5)

Drug: BMS-986177; Drug: Aspirin

Interventions

BMS-986177 DRUG

BMS-986177 capsule

BMS-986177 (Part 1); BMS-986177 (Part 2); BMS-986177 (Part 3); BMS-986177 + Aspirin (Part 3); BMS-986177 + Aspirin + Clopidogrel (Part 1); BMS-986177 + Clopidogrel (Part 2)

Placebo (for BMS-986177) OTHER

BMS-986177 placebo match capsule

BMS-986177 placebo + Aspirin (Part 3); BMS-986177 placebo + Aspirin + Clopidogrel (Part 1); BMS-986177 placebo + Clopidogrel (Part 2)

Clopidogrel DRUG

Clopidogrel tablet

BMS-986177 + Aspirin + Clopidogrel (Part 1); BMS-986177 + Clopidogrel (Part 2); BMS-986177 placebo + Aspirin + Clopidogrel (Part 1); BMS-986177 placebo + Clopidogrel (Part 2)

Aspirin DRUG

Aspirin tablet

BMS-986177 + Aspirin (Part 3); BMS-986177 + Aspirin + Clopidogrel (Part 1); BMS-986177 placebo + Aspirin (Part 3); BMS-986177 placebo + Aspirin + Clopidogrel (Part 1)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

Related Publications (1)

• 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.

  PMID: 39025971 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

milvexian; Clopidogrel; Aspirin

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: October 4, 2018
• Primary Completion: February 19, 2019
• Study Completion: February 19, 2019
• Last Updated: September 29, 2021

Record last verified: 2021-09

Locations

US (1)