Biomarkers of Prednisolone Treatment (P05888)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00971724

Enrollment

Registered

2009-09-04

Start date

2006-05-31

Completion date

2008-03-31

Last updated

2015-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glucose Intolerance, Hyperglycemia, Insulin Resistance

Keywords

Prednisolone, Glucocorticoids

Brief summary

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.

Interventions

DRUGPlacebo

Oral administration, once daily, for 15 days

DRUGPrednisolone

Oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
To identify a biomarker or biomarker-set for adverse metabolic effects of various doses of prednisolone	Day 1 and day 15

Secondary

Measure	Time frame
To describe the PK of prednisolone and PD of a series of biomarkers	Day 1 and day 15

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026