A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males

Immunoscience Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198013
• Other study ID #: IM125-001
• Status: Completed
• Phase: Phase 1
• Start date: November 11, 2008
• Est. completion date: May 18, 2009

Study information

• Verified date: June 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 18, 2009
• Est. primary completion date: May 18, 2009
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Immunoscience

Intervention

Drug:
• Prednisolone
Specified dose on specified days
• BMS-791826
Specified dose on specified days
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	safety and tolerability	Up to 34 days
Primary	Incidence of serious adverse events (SAEs)	safety and tolerability	Up to 34 days