- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03660436
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants
December 17, 2018 updated by: Bristol-Myers Squibb
An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects
The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
131
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- PRA Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2
Exclusion Criteria:
- Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
- Positive anti- John Cunningham virus (JCV) antibody test at Screening
- History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy
Other protocol defined inclusion/exclusion criteria could apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BMS-986165 + MMF
Oral administration
|
Specified dose on specified days
Specified dose on specified days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)
Time Frame: 18 days
|
18 days
|
Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA
Time Frame: 18 days
|
18 days
|
AUC extrapolated to infinity (AUC[INF]) of MPA
Time Frame: 18 days
|
18 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of adverse events (AE)
Time Frame: Up to 48 days
|
Up to 48 days
|
Number of serious adverse events (SAE)
Time Frame: Up to 48 days
|
Up to 48 days
|
Number of AEs leading to discontinuation
Time Frame: Up to 48 days
|
Up to 48 days
|
Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results
Time Frame: 18 days
|
18 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2018
Primary Completion (Actual)
October 10, 2018
Study Completion (Actual)
October 18, 2018
Study Registration Dates
First Submitted
September 4, 2018
First Submitted That Met QC Criteria
September 4, 2018
First Posted (Actual)
September 6, 2018
Study Record Updates
Last Update Posted (Actual)
December 19, 2018
Last Update Submitted That Met QC Criteria
December 17, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM011-071
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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