The Dose Response of Prednisone on Biochemical and Clinical Makers in Adult Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: Placebo; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02767089

A9001309

Details and patient eligibility

About

The purpose of this study is to further access the utility of biochemical and clinical biomarkers for glucocorticoid-mediated anti-inflammatory effects and safety endpoints against which dissociated agonists of the glucocorticoid receptor (DAGR) will be evaluated in adult healthy volunteers.

Enrollment: 37 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male or females willing to be confined and comply with scheduled visits
• Women are to be surgically sterile.

Exclusion criteria

• History of febrile illness within 5 days prior to the first dose
• Positive urine drug screen
• Treatment with an investigational product within 30 days prior to the first dose of study medication

Trial design

37 participants in 7 patient groups

Sequence A

Other group

Description:

Period 1: Placebo Period 2: Prednisone 2.5 mg Period 3: Prednisone 10 mg

Treatment:

Drug: Placebo

Drug: Prednisone

Sequence B

Other group

Description:

Period 1: Prednisone 2.5 mg Period 2: Prednisone 5 mg Period 3: Prednisone 20 mg

Treatment:

Drug: Prednisone

Sequence C

Other group

Description:

Period 1: Prednisone 5 mg Period 2: Prednisone 10 mg Period 3: Prednisone 40 mg

Treatment:

Drug: Prednisone

Sequence D

Other group

Description:

Period 1: Prednisone 10 mg Period 2: Prednisone 20 mg Period 3: Prednisone 60 mg

Treatment:

Drug: Prednisone

Sequence E

Other group

Description:

Period 1: Prednisone 20 mg Period 2: Prednisone 40 mg Period 3: Placebo

Treatment:

Drug: Placebo

Drug: Prednisone

Sequence F

Other group

Description:

Period 1: Prednisone 40 mg Period 2: Prednisone 60 mg Period 3: Prednisone 2.5 mg

Treatment:

Drug: Prednisone

Sequence G

Other group

Description:

Period 1: Prednisone 60 mg Period 2: Placebo Period 3: Prednisone 5 mg

Treatment:

Drug: Placebo

Drug: Prednisone