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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02534636




Registration number
NCT02534636
Ethics application status
Date submitted
23/08/2015
Date registered
27/08/2015
Date last updated
28/12/2016

Titles & IDs
Public title
Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis
Scientific title
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
Secondary ID [1] 0 0
IM011-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Part A: Single ascending dose - BMS-986165 or Placebo specified dose on specified days

Experimental: Part B: Multiple ascending dose - BMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days

Experimental: Part C: Multiple ascending dose - BMS-986165 or Placebo specified dose on specified days

Experimental: Part D: Relative Bioavailability - BMS-986165 (Liquid) + BMS-986165 (Capsule) + Famotidine specified dose on specified days
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Approximately 3 months
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Approximately 3 months
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Approximately 3 months
Primary outcome [4] 0 0
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
Timepoint [4] 0 0
Approximately 3 months
Secondary outcome [1] 0 0
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as heart rate in healthy subjects of any ethnic background (Parts A, B, C, D)
Timepoint [1] 0 0
Approximately 3 months
Secondary outcome [2] 0 0
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as PR interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Timepoint [2] 0 0
Approximately 3 months
Secondary outcome [3] 0 0
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QRS interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Timepoint [3] 0 0
Approximately 3 months
Secondary outcome [4] 0 0
Effect of BMS-986165 on electrocardiographic (ECG) parameters such as QTc interval in healthy subjects of any ethnic background (Parts A, B, C, D)
Timepoint [4] 0 0
Approximately 3 months

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com



* Healthy Male and Female participants
* 18 to 50 years of age (Parts A-D)
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT02534636
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02534636