Biomarkers of Prednisolone Treatment (P05888)

Primary objective:

* To identify a biomarker or biomarker-set for the adverse metabolic effects of various doses of prednisolone treatment.

Secondary objectives:

* To describe the PK of prednisolone and PD of a series of biomarkers. * To identify biomarkers that reflect side effects of prednisolone. * To elucidate part of the mechanisms by which prednisolone induces metabolic changes.

Completed

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Key information

Conditions

Insulin Resistance Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

22 < BMI < 30
fasting glucose < 5.6 mmol/L and glucose < 7.8 mmol/L 2hr after OGTT
able and willing to sign informed consent
history of good physical and mental health
subject smokes less than 5 cigarettes per day
able to keep a normal day and night rhythm

Exclusion criteria

allergy to prednisolone
glucocorticoid use during last 3 months prior to study
use of any drug or substance
history of familiar diabetes type 2
clinically relevant history or presence of any medical disorder
clinically relevant abnormal lab or ECG
positive drug or alcohol screen, positive hepatitis B or C surface antigen
donation of blood (>100 mL) within 90 days prior to the first dose

Treatment and study plan

Placebo

Drug

Oral administration, once daily, for 15 days

Prednisolone

Drug

Oral administration

Primary outcomes

To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone

Time frame: Day 1 and day 15

Secondary outcomes

To describe the PK of prednisolone and PD of a series of biomarkers

Time frame: Day 1 and day 15

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Placebo-controlled, Double-blind, Single-center Study Using Multiple Doses of Prednisolone to Quantify Effects on Selected Biomarkers and Assess Pharmacokinetics in Healthy Males

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2008
First posted: Sep 4, 2009
Registry last updated: May 22, 2015

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.

Published trials that share one or more normalized conditions with this study.

Completed