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

Healthy Clinical Trial

Official title:

A Double-Blind (3rd Party Open), Randomized, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Single Doses Of PF-04418948 In Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002963
• Other study ID #: B0631001
• Status: Completed
• Phase: Phase 1
• First received: October 27, 2009
• Last updated: October 22, 2010
• Start date: September 2009
• Est. completion date: February 2010

Study information

• Verified date: October 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agenecy for Medicines and Health Products.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-04418948
solution, 30 mg, single
• PF-04418948
solution, 100 mg, single
• PF-04418948
solution, 300 mg, single
• PF-04418948
solution, 1000 mg, single
• PF-04418948
solution, 3000 mg, single
• PF-04418948
solution, 4500 mg, single
• PF-04418948
solution, 6000 mg, single

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma pharmacokinetic parameters: Cmax, Tmax, AUClast, AUCtau, AUCinf, Cav, CL/F, V/F, t1/2		240 hours	No
Primary	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	No
Secondary	Pharmacodynamics: Emax (maximum observed increase in TNFa 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	No

External Links

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