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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01012310

Enrollment

Registered

2009-11-13

Start date

2009-11-30

Completion date

2010-04-30

Last updated

2010-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

pharmacokinetics safety tolerability multiple dosing

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).

Interventions

DRUGPF-04531083 or Placebo

Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of PF-04531083 Cmax, Tmax, AUCtau, AUCinf, T1/2, accumulation index	days 1-15
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

Measure	Time frame
pharmacokinetics of alternative formulations	days 1-15

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026