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

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ClinicalTrials.gov Identifier: NCT03198013
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Immunoscience Drug: Prednisolone Drug: BMS-791826 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 11, 2008
Actual Primary Completion Date : May 18, 2009
Actual Study Completion Date : May 18, 2009


Arm Intervention/treatment
Experimental: Module A
Single Ascending Dose
Drug: Prednisolone
Specified dose on specified days

Drug: BMS-791826
Specified dose on specified days

Drug: Placebo
Specified dose on specified days

Experimental: Module B
Multiple Ascending Dose
Drug: Prednisolone
Specified dose on specified days

Drug: BMS-791826
Specified dose on specified days

Drug: Placebo
Specified dose on specified days




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198013


Locations
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Australia
Local Insitution
Melbourne, Australia, 3004
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03198013     History of Changes
Other Study ID Numbers: IM125-001
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

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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
Additional relevant MeSH terms:
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Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents