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

Pfizer logo

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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