A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males
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
1 other identifier
interventional
120
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2008
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2009
CompletedFirst Submitted
Initial submission to the registry
June 22, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedJune 9, 2020
June 1, 2020
6 months
June 22, 2017
June 5, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events (AEs)
safety and tolerability
Up to 34 days
Incidence of serious adverse events (SAEs)
safety and tolerability
Up to 34 days
Study Arms (2)
Module A
EXPERIMENTALSingle Ascending Dose
Module B
EXPERIMENTALMultiple Ascending Dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local Institution
Melbourne, Victoria, 3004, Australia
Related Publications (1)
Hu Y, Carman JA, Holloway D, Kansal S, Fan L, Goldstine C, Lee D, Somerville JE, Latek R, Townsend R, Johnsen A, Connolly S, Bandyopadhyay S, Shadick N, Weinblatt ME, Furie R, Nadler SG. Development of a Molecular Signature to Monitor Pharmacodynamic Responses Mediated by In Vivo Administration of Glucocorticoids. Arthritis Rheumatol. 2018 Aug;70(8):1331-1342. doi: 10.1002/art.40476. Epub 2018 Jul 12.
PMID: 29534336DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2017
First Posted
June 23, 2017
Study Start
November 11, 2008
Primary Completion
May 18, 2009
Study Completion
May 18, 2009
Last Updated
June 9, 2020
Record last verified: 2020-06