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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01012310
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Duration (Months): 5
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: PF-04531083 or Placebo; Drug: PF-04531083 or Placebo; Drug: PF-04531083 or Placebo; Drug: PF-04531083 or Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1	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.
Experimental: Cohort 2	Drug: PF-04531083 or Placebo; Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
Experimental: Cohort 3	Drug: PF-04531083 or Placebo; Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
Experimental: Cohort 4	Drug: PF-04531083 or Placebo; A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index [days 1-15]

2. 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]

Secondary Outcome Measures

1. pharmacokinetics of alternative formulations [days 1-15]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Bruxelles		Belgium	1070

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01012310
• Other Study ID Numbers: B1351002
• First Posted: Nov 13, 2009
• Last Update Posted: Apr 16, 2010
• Last Verified: Apr 1, 2010

• Keywords provided by , ,: pharmacokinetics safety tolerability multiple dosing

Study Results

No Results Posted as of Apr 16, 2010