- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03198013
A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males
June 5, 2020 updated by: Bristol-Myers Squibb
Placebo-Controlled, Double-Blind, Ascending Single and Multiple Oral Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-791826 and to Assess Its Marker Specific Pharmacodynamics in Relation to Prednisolone in Healthy Males
The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
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
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Local Institution
-
-
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 55 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
- Signed informed consent
Exclusion Criteria:
- Sexually active fertile men not using effective birth control (barrier contraception) if their partners are women of childbearing potential (WOCBP)
- Any significant acute or chronic medical illness
- History of Gilbert's disease
Other protocol inclusion/exclusion criteria may 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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Module A
Single Ascending Dose
|
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
|
Experimental: Module B
Multiple Ascending Dose
|
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events (AEs)
Time Frame: Up to 34 days
|
safety and tolerability
|
Up to 34 days
|
Incidence of serious adverse events (SAEs)
Time Frame: Up to 34 days
|
safety and tolerability
|
Up to 34 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)
November 11, 2008
Primary Completion (Actual)
May 18, 2009
Study Completion (Actual)
May 18, 2009
Study Registration Dates
First Submitted
June 22, 2017
First Submitted That Met QC Criteria
June 22, 2017
First Posted (Actual)
June 23, 2017
Study Record Updates
Last Update Posted (Actual)
June 9, 2020
Last Update Submitted That Met QC Criteria
June 5, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IM125-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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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