MedDataX Logo

Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

NCT ID: NCT02341638

Last Updated: 2017-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Short and Long Intravenous Infusion Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-962212 in Healthy Subjects

NCT03197779

Thrombosis
COMPLETED PHASE1

A Randomized, Double Blind Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects

NCT02790125

Healthy
COMPLETED PHASE1

Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects

NCT02257151

Healthy Adult
COMPLETED PHASE1

A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K

NCT01364974

Healthy Subjects Pharmacokinetics of ASP015K Pharmacodynamics
COMPLETED PHASE1

Placebo-Controlled, Single and Multiple Ascending Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986089 in Healthy Adult Subjects

NCT02145234

Healthy Adults
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Maximum Age:

Part A SAD 65 years

Part B MAD 75 years

Part C MAD Japanese 75 years

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part A Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part A Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part A Panel 4: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part A Panel 5: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part A Panel 6: BMS-986141 or Placebo

BMS-986141 or Placebo single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part A Panel 7: BMS-986141

Single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Part A Panel 8: BMS-986141

Single dose by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Part B Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part B Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part B Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part C Panel 1: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part C Panel 2: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part C Panel 3: BMS-986141 or Placebo

BMS-986141 or Placebo by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Part D Panel 1: BMS-986141 and Aspirin

BMS-986141 and Aspirin by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Part D Panel 1: Placebo matching BMS-986141 and Aspirin

BMS-986141 placebo and Aspirin by mouth as specified

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Part E Panel 1: BMS-986141 and Itraconazole

BMS-986141 and Itraconazole by mouth as specified

Group Type EXPERIMENTAL

BMS-986141

Intervention Type DRUG

Itraconazole

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BMS-986141

Intervention Type DRUG

Placebo

Intervention Type DRUG

Aspirin

Intervention Type DRUG

Itraconazole

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/\[height(m)\]2
3. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

Exclusion Criteria

1. Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

West Coast Clinical Trials, Llc

Cypress, California, United States

Site Status

Ppd Development, Lp

Austin, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Merali S, Wang Z, Frost C, Meadows-Shropshire S, Hawthorne D, Yang J, Seiffert D. First-in-human study to assess the safety, pharmacokinetics, and pharmacodynamics of BMS-986141, a novel, reversible, small-molecule, PAR4 agonist in non-Japanese and Japanese healthy participants. Platelets. 2023 Dec;34(1):2222846. doi: 10.1080/09537104.2023.2222846.

Reference Type DERIVED
PMID: 37394920 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CV006-003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Randomized, Placebo-Controlled, Double-Blind, Ascending Single and Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-963272 in Healthy Subjects
NCT02327273 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD5148 in Healthy Adults
NCT06469151 COMPLETED PHASE1
A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants
NCT04082741 WITHDRAWN PHASE1
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
NCT02293629 COMPLETED PHASE1
A Phase 1, First-in-Human Study of BMS-986421 in Healthy Participants
NCT05517837 TERMINATED EARLY_PHASE1
A Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of Single and Multiple Doses of BMS-986209 in Healthy Participants
NCT04154800 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
NCT04736134 COMPLETED PHASE1
A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers
NCT06103877 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4144 Following Single and Multiple Ascending Doses Via Oral Administration to Healthy Participants
NCT06122714 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K in Healthy Subjects
NCT02141425 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
NCT05143905 COMPLETED PHASE1
A Study to Assess the Safety, Tolerability and Pharmacokinetics of ASP015K
NCT01387087 COMPLETED PHASE1
A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants
NCT06138795 COMPLETED PHASE1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of AZD3974 in Healthy Participants
NCT07290283 RECRUITING PHASE1
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 In Healthy Participants
NCT06311760 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants
NCT06086886 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986325 in Healthy Japanese Participants
NCT05813717 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986447 in Healthy Participants
NCT05760937 COMPLETED PHASE1
Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
NCT01150812 TERMINATED PHASE1
Phase I Multiple Ascending Dose Study for AZD 7268 in Healthy Volunteers
NCT00861718 COMPLETED PHASE1
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 in Healthy Volunteers
NCT00940212 COMPLETED PHASE1
A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986446 in Healthy Participants and Healthy Participants of Japanese Ethnicity
NCT06084598 COMPLETED PHASE1
Investigating Safety, Tolerability and Pharmakinetics When Giving Single and Fractionated Doses of AZD3241 to Healthy Volunteers
NCT00729443 COMPLETED PHASE1
A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.
NCT06995820 RECRUITING PHASE1
Single and Multiple Ascending Doses of AZD1981 in Japan
NCT00698282 COMPLETED PHASE1