Multiple Dose Escalation Trial Of PF-04308515 In Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: PF-04308515 Tablet; Drug: PF-04308515

• Registration Number: NCT01101932
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-11
• Study First Submitted QC: 2010-04-08
• Study First Posted: 2010-04-12
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-21
• Last Update Posted: 2011-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(Part 1) Solution Placebo	Placebo	-
(Part 2) PF-04308515 Tablet	PF-04308515 Tablet	-
(Part 1) PF-04308515	PF-04308515	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States