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A Study to Determine the Pharmacokinetic Profile of BMS-986165 Tablets

NCT ID: NCT04065932

Last Updated: 2021-01-06

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-22

Study Completion Date

2019-12-10

Brief Summary

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A Study to Determine the Drug Level Profile of Different formulations of BMS-986165 Tablets

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Detailed Description

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Conditions

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Lupus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-985165-01 prototype formulation 1

Group Type EXPERIMENTAL

BMS-986165-01

Intervention Type DRUG

Participants will receive BMS- 986165 -01 in prototype formulation

BMS-986165 Tablet

Group Type EXPERIMENTAL

BMS-986165 Tablet

Intervention Type DRUG

Participants will receive BMS-986165 in tablet form.

BMS-985165-01 prototype formulation 2

Group Type EXPERIMENTAL

BMS-986165-01

Intervention Type DRUG

Participants will receive BMS- 986165 -01 in prototype formulation

BMS-985165-01 prototype formulation 3

Group Type EXPERIMENTAL

BMS-986165-01

Intervention Type DRUG

Participants will receive BMS- 986165 -01 in prototype formulation

BMS-985165-01 prototype formulation 3 or 4

Group Type EXPERIMENTAL

BMS-986165-01

Intervention Type DRUG

Participants will receive BMS- 986165 -01 in prototype formulation

Famotidine

Intervention Type DRUG

Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine

BMS-985165-01 prototype formulation 3, 4 or 5

Group Type EXPERIMENTAL

BMS-986165-01

Intervention Type DRUG

Participants will receive BMS- 986165 -01 in prototype formulation

Famotidine

Intervention Type DRUG

Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine

Interventions

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BMS-986165-01

Participants will receive BMS- 986165 -01 in prototype formulation

Intervention Type DRUG

BMS-986165 Tablet

Participants will receive BMS-986165 in tablet form.

Intervention Type DRUG

Famotidine

Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients must be willing and able to complete all study-specific procedures and visits
* Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
* Normal renal function at screening

Exclusion Criteria

* History or presence of chronic bacterial, viral infection, or autoimmune disorder
* Active TB requiring treatment or documented latent TB within the previous 3 years
* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
* WOCBP (women of childbearing potential) must have negative serum or urine pregnancy test.
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

Locations

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Quotient Sciences

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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IM011-020

Identifier Type: -

Identifier Source: org_study_id

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