MedDataX Logo

Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis

NCT ID: NCT02534636

Last Updated: 2016-12-28

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-11-30

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 establish if BMS-986165 is safe and effective at treating autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for inhibiting autoimmune conditions. This study will be the first time this drug is given to humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part A will investigate single oral doses of drug. Part B will investigate giving the drug daily for 14 days. Part C will investigate daily doses for 14 days in healthy volunteers with Japanese decent. Part D will investigate whether food, stomach acidity or giving the drug in a capsule makes a difference to the safety and potential use of this drug.

Detailed Description

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

Conditions

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

Healthy Subjects

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

Part A: Single ascending dose

BMS-986165 or Placebo specified dose on specified days

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Placebo

Intervention Type OTHER

Part B: Multiple ascending dose

BMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Interferon alpha-2a recombinant

Intervention Type DRUG

Placebo

Intervention Type OTHER

Part C: Multiple ascending dose

BMS-986165 or Placebo specified dose on specified days

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Placebo

Intervention Type OTHER

Part D: Relative Bioavailability

BMS-986165 (Liquid) + BMS-986165 (Capsule) + Famotidine specified dose on specified days

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Famotidine

Intervention Type DRUG

Interventions

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

BMS-986165

Intervention Type DRUG

Interferon alpha-2a recombinant

Intervention Type DRUG

Famotidine

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Healthy Male and Female participants
* 18 to 50 years of age (Parts A-D)

Exclusion Criteria

* Participants that had recent infections
* Participants with low blood pressure or increased heart rate
* Participants with any chronic health related problems
* Participants with active cancer within the last 5 years
* Participants with any other major medical illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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.

Local Institution

Melbourne, Victoria, Australia

Site Status

Countries

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

Australia

References

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

Catlett IM, Aras U, Hansen L, Liu Y, Bei D, Girgis IG, Murthy B. First-in-human study of deucravacitinib: A selective, potent, allosteric small-molecule inhibitor of tyrosine kinase 2. Clin Transl Sci. 2023 Jan;16(1):151-164. doi: 10.1111/cts.13435. Epub 2022 Nov 22.

Reference Type DERIVED
PMID: 36325947 (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.

IM011-002

Identifier Type: -

Identifier Source: org_study_id