A Study of Experimental Medication BMS-986235 in Healthy Subjects

NCT ID: NCT03335553

Last Updated: 2022-03-31

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2021-07-02

Brief Summary

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This is a study of experimental medication BMS-986235 in healthy subjects.

Detailed Description

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Conditions

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Mediators of Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single ascending dose (SAD): BMS-986235 or Placebo

BMS-986235 or Placebo oral dose

Group Type EXPERIMENTAL

BMS-986235

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Multiple ascending dose (MAD): BMS-986235 or Placebo

BMS-986235 or Placebo oral dose

Group Type EXPERIMENTAL

BMS-986235

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986235

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients must be normal healthy volunteers as determined by no clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations
* Patients must have a body mass index (BMI) of 18 - 30 mg/kg2, inclusive

Exclusion Criteria

* Patients that are pregnant
* Patient with any significant acute or chronic medical illness
* Patient with a current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
* Patient with any surgery within 12 weeks of study treatment administration
* Patient with any gastrointestinal surgery that could impact upon the absorption of study drug
* Patient who donated blood to a blood bank or in a clinical study (except a screening visit) within 12 weeks of study drug administration (within 2 weeks for plasma only)
* Patient who received a blood transfusion within 12 weeks of study drug administration
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Anaheim Clinical Trials

Anaheim, California, United States

Site Status

PRA Health Sciences

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Singh J, Jackson KL, Fang H, Gumanti A, Claridge B, Tang FS, Kiriazis H, Salimova E, Parker AM, Nowell C, Woodman OL, Greening DW, Ritchie RH, Head GA, Qin CX. Novel formylpeptide receptor 1/2 agonist limits hypertension-induced cardiovascular damage. Cardiovasc Res. 2024 Sep 21;120(11):1336-1350. doi: 10.1093/cvr/cvae103.

Reference Type DERIVED
PMID: 38879891 (View on PubMed)

Related Links

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Other Identifiers

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CV018-001

Identifier Type: -

Identifier Source: org_study_id

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