Back to resultsAn Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants
Primary Purpose
Psoriasis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986165
Cyclosporine
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index 18.0 to 32.0 kg/m2
- Weight ≥ 50 kg
Exclusion Criteria:
- Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
- History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
- Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- History of administration of live vaccines within 60 days before screening
- Any history or risk for tuberculosis (TB)
Other protocol defined inclusion/exclusion criteria could apply
Sites / Locations
- PRA Health Sciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BMS-986165 and cyclosporine
Arm Description
BMS-986165 and cyclosporine administered orally
Outcomes
Primary Outcome Measures
Maximum concentration (Cmax)
Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])
Secondary Outcome Measures
Adverse events (AEs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03419910
Brief Title
An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants
Official Title
An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
May 4, 2018 (Actual)
Study Completion Date
May 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMS-986165 and cyclosporine
Arm Type
Experimental
Arm Description
BMS-986165 and cyclosporine administered orally
Intervention Type
Drug
Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cyclosporine
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Maximum concentration (Cmax)
Time Frame
24 hours
Title
Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Adverse events (AEs)
Time Frame
Up to 20 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Body mass index 18.0 to 32.0 kg/m2
Weight ≥ 50 kg
Exclusion Criteria:
Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
History of administration of live vaccines within 60 days before screening
Any history or risk for tuberculosis (TB)
Other protocol defined inclusion/exclusion criteria could apply
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
PRA Health Sciences
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants
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