Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06291874; Other: placebo

• Registration Number: NCT01794364
• Lead Sponsor: Pfizer

Brief Summary

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-21
• Study Start: 2013-01
• Study First Submitted QC: 2013-02-15
• Study First Posted: 2013-02-18
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-01
• Last Update Posted: 2013-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Healthy male and/or female subjects of non childbearing potential.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Cohort A	placebo	Each subjects in Cohort A will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state.
Experimental: Cohort A	PF-06291874	Each subjects in Cohort A will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state.

Primary Outcome Measures

Name	Time	Method
Apparent Volume of Distribution (Vz/F)	0-72/dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0-72/dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)]	0-72/dose
Maximum Observed Plasma Concentration (Cmax)	0-72/dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)	0-72/dose
Plasma Decay Half-Life (t1/2)	0-72/dose
Apparent Oral Clearance (CL/F)	0-72/dose

Trial Locations

Locations (1)

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