A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Prednisolone; Drug: PF-04171327; Drug: Placebo; Drug: PF-04171327 Tablet; Drug: Placebo Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00812825

A9391002

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-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.

Enrollment: 78 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.

Exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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78 participants in 5 patient groups, including a placebo group

PF-04173127

Experimental group

Treatment:

Drug: PF-04171327

Prednisolone

Active Comparator group

Treatment:

Drug: Prednisolone

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Solution Placebo

Sham Comparator group

Treatment:

Drug: Placebo Solution

PF-04171327 Tablet

Experimental group

Treatment:

Drug: PF-04171327 Tablet