Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

Healthy Volunteers Clinical Trial

Official title:

A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012310
• Other study ID #: B1351002
• Status: Completed
• Phase: Phase 1
• First received: November 11, 2009
• Last updated: April 15, 2010
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Belgian Health Authority
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects btween the ages of 18-55 years

• Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).

Exclusion Criteria:

• Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

• A positive urine drug screen.

• History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening

• Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.

• Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.

Study Design

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PF-04531083 or Placebo
Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
• PF-04531083 or Placebo
Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
• PF-04531083 or Placebo
Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
• PF-04531083 or Placebo
A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.

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	Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index		days 1-15	No
Primary	Safety of subjects following multiple dosing of PF-04531083 (adverse events, vital signs measurements, telemetry, 12-lead ECGs, physical examination findings, blood and urine safety tests)		days 1-15	Yes
Secondary	pharmacokinetics of alternative formulations		days 1-15	No

External Links

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