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

NCT ID: NCT02790125

Last Updated: 2017-11-24

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

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-28

Study Completion Date

2017-11-07

Brief Summary

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The primary purpose of this study is to determine if single doses of BMS-986166 are safe and well tolerated in healthy male subjects and female subjects of non-childbearing potential.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dose Panel 1

BMS-986166 or Placebo matching BMS-986166

Single oral dose of solution as specified

Group Type EXPERIMENTAL

BMS-986166

Intervention Type DRUG

Placebo matching BMS-986166

Intervention Type DRUG

Dose Panel 2

BMS-986166 or Placebo matching BMS-986166

Single oral dose of solution as specified

Group Type EXPERIMENTAL

BMS-986166

Intervention Type DRUG

Placebo matching BMS-986166

Intervention Type DRUG

Dose Panel 3

BMS-986166 or Placebo matching BMS-986166

Single oral dose of solution as specified

Group Type EXPERIMENTAL

BMS-986166

Intervention Type DRUG

Placebo matching BMS-986166

Intervention Type DRUG

Dose Panel 4

BMS-986166 or Placebo matching BMS-986166

Multiple ascending solid dose formulation as specified

Group Type EXPERIMENTAL

BMS-986166

Intervention Type DRUG

Placebo matching BMS-986166

Intervention Type DRUG

Dose Panel 5a/b/c

BMS-986166

Single oral solid dose formulation under fasting/fed/fasting with famotidine conditions

Group Type EXPERIMENTAL

BMS-986166

Intervention Type DRUG

Interventions

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BMS-986166

Intervention Type DRUG

Placebo matching BMS-986166

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy female subjects of non-childbearing potential or male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations
* Ages 18 to 55 years
* Female subjects must provide documentation of an acceptable method of surgical sterilization or meet the protocol criteria for menopause

Exclusion Criteria

* Any acute or chronic medical illness judged to be clinically significant by the Investigator and/or Sponsor medical monitor
* Any acute or chronic bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C, as defined in the protocol
* History of heart disease, neurological disease, eye disorders or gastrointestinal disorders or surgery (including cholecystectomy)
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs or clinical laboratory tests
* Smoking or nicotine use, drug or alcohol abuse within 6 months of starting the study
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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PPD Development, LLC

Austin, Texas, United States

Site Status

Countries

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United States

References

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Singhal S, Girgis IG, Xie J, Dutta S, Shevell DE, Throup J. The safety and pharmacokinetics of a novel, selective S1P1R modulator in healthy participants. Expert Opin Investig Drugs. 2020 Apr;29(4):411-422. doi: 10.1080/13543784.2020.1742322.

Reference Type DERIVED
PMID: 32306792 (View on PubMed)

Related Links

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

BMS Clinical Trial Patient Recruiting

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

Investigator Inquiry Form

Other Identifiers

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IM018-001

Identifier Type: -

Identifier Source: org_study_id