Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

Phase 1CompletedNCT01101932

Pfizer58 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-04308515DRUG

PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.

PlaceboDRUG

Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.

PF-04308515 TabletDRUG

Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Safety and tolerability of multiple doses of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs).

Time frame: 14 days

Characterization of pharmacokinetic parameters of PF-04308515 after multiples doses which will include: Cmax, Tmax, AUC, CL/F, Vz/F, t1/2. Urinary excretion including AE% and CLr will be assessed at steady state.

Time frame: 14 days

Change from baseline will be utilized to assess PF-04308515's pharmacodynamic effect on biochemical and metabolic biomarkers after 14 days of dosing.

Time frame: 14 days

For the tablet pharmacokinetics:Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, t1/2 will be calculated from the PF-04308515 plasma concentration versus time data.

Time frame: 1 day

Safety and tolerability of 1 oral dose of a tablet formulation of PF-04308515 as assessed by adverse event reporting, clinical laboratory results, vital signs, physical examinations and electrocardiograms (ECGs).

Time frame: 1 day

Data from ClinicalTrials.gov

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