Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986165 in Healthy Subjects and to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of BMS-986165 in Subjects With Moderate to Severe Psoriasis
Sponsor study identifier
interventional
140
1 country
1
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2016
Actual (reported)Study Completion
November 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 23, 2015
Actual (reported)August 27, 2015
Actual (reported)October 2015
Date type not reportedThis date has not been verified as actual or estimated.
November 2016
Actual (reported)November 2016
Actual (reported)Safety of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Adverse Event (AE), Serious adverse event (SAE)
Approximately 3 months
Tolerability of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Approximately 3 months
Safety of a multiple oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Approximately 3 months
Tolerability of a multiple oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Approximately 3 months
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Approximately 3 months
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Approximately 3 months
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Approximately 3 months
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Approximately 3 months
BMS-986165 or Placebo specified dose on specified days
BMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
Local Institution
Melbourne, Victoria, 3004, Australia
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.
Bristol Myers Squibb
Bristol-Myers Squibb
140 participants (actual enrollment reported by the registry).
First Submitted
August 23, 2015
First Posted
August 27, 2015
Study Start
October 2015
Date type not reportedThis date has not been verified as actual or estimated.
BMS-986165 or Placebo specified dose on specified days
BMS-986165 (Liquid) + BMS-986165 (Capsule) + Famotidine specified dose on specified days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
November 2016
Actual (reported)Study Completion
November 2016
Actual (reported)Last Updated
December 28, 2016
Record last verified: 2016-10
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Source: ClinicalTrials.gov.
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