A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: PF-04308515; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00990015

B0861001

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males between 18 and 55 years, inclusive
• Healthy females between 18 and 44 years, inclusive.
• Women need to be surgically sterile

Exclusion criteria

• Evidence or history of clinically significant disease
• Post-menopausal women
• History of intolerance or significant adverse effects with glucocorticoids

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 2 patient groups, including a placebo group

PF-04308515

Experimental group

Treatment:

Drug: PF-04308515

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo