A Study To Investigate The Safety And Toleration Of A Single Dose Of PF-04418948 In Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04418948

• Registration Number: NCT01002963
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to investigate safety and toleration of single oral doses as well as the time course of PF-04418948 concentration in the blood following dosing by oral solution.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-27
• Study First Posted: 2009-10-28
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-22
• Last Update Posted: 2010-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

Inclusion Criteria

• Healthy male subjects between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs).

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• A positive urine drug screen.
• History of regular alcohol consumption exceeding 21 drinks/week for males.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-04418948 1000 mg	PF-04418948	-
PF-04418948 30 mg	PF-04418948	-
PF-04418948 100 mg	PF-04418948	-
PF-04418948 300 mg	PF-04418948	-
PF-04418948 4500 mg	PF-04418948	-
PF-04418948 3000 mg	PF-04418948	-
PF-04418948 6000 mg	PF-04418948	-

Primary Outcome Measures

Name	Time	Method
Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2	240 hours
Safety: Adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood safety tests, fecal occult blood (FOB), cardiac troponin measurements, urine safety tests (KIM-1 measurements and creatinine).	240 hours

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics: Emax (maximum observed increase in TNFα concentration from pre-dose level) TEmax (time to Emax), AUEClast, AUECt (where t will be a defined timepoint) and maximum n-fold increase in concentration from pre-dose level.	48 hours

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium