An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male Participants
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
1 other identifier
interventional
54
1 country
1
Brief Summary
This is an investigational study of Cyclosporine on the experimental medication BMS-986165 in healthy male participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2018
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedStudy Start
First participant enrolled
March 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2018
CompletedMarch 18, 2020
March 1, 2020
2 months
January 29, 2018
March 17, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Maximum concentration (Cmax)
24 hours
Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])
24 hours
Secondary Outcomes (1)
Adverse events (AEs)
Up to 20 days
Study Arms (1)
BMS-986165 and cyclosporine
EXPERIMENTALBMS-986165 and cyclosporine administered orally
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PRA Health Sciences
Salt Lake City, Utah, 84124, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2018
First Posted
February 5, 2018
Study Start
March 5, 2018
Primary Completion
May 4, 2018
Study Completion
May 4, 2018
Last Updated
March 18, 2020
Record last verified: 2020-03