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OpenTrials
Completed

NCT Number: NCT03198013

A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) 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

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Key information

Conditions

Immunoscience

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution

Melbourne, Victoria, 3004, Australia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

Specified dose on specified days

BMS-791826

Drug

Specified dose on specified days

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Incidence of Adverse Events (AEs)

    Time frame: Up to 34 days

    safety and tolerability

  2. Incidence of serious adverse events (SAEs)

    Time frame: Up to 34 days

    safety and tolerability

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 23, 2017
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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