Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-04308515 Tablet; Drug: PF-04308515; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01101932

B0861002

Details and patient eligibility

About

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04308515 in healthy volunteers for 14 days as well as one oral dose of a tablet formulation administered for 1 day.

Enrollment: 58 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
• Females are required to be surgically sterile

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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58 participants in 3 patient groups, including a placebo group

(Part 1) PF-04308515

Experimental group

Treatment:

Drug: PF-04308515

(Part 1) Solution Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

(Part 2) PF-04308515 Tablet

Experimental group

Treatment:

Drug: PF-04308515 Tablet