NCT00992342

Brief Summary

The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
23 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

March 18, 2010

Status Verified

March 1, 2010

Enrollment Period

4 months

First QC Date

October 8, 2009

Last Update Submit

March 17, 2010

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood (including creatine kinase) and urine safety tests and physical examination.

    22 days

Secondary Outcomes (1)

  • Pharmacokinetic parameters: Cmax, Tmax, AUCτ, t½, accumulation ratio,

    22 days

Study Arms (3)

PF-03893787 5 mg

EXPERIMENTAL
Drug: PF-03893787

PF-03893787 15 mg

EXPERIMENTAL
Drug: PF-03893787

PF-03893787 50 mg

EXPERIMENTAL
Drug: PF-03893787

Interventions

PF-03893787DRUG

oral solution, 5 mg, QD for 14 days

PF-03893787 5 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects and females of non-childbearing potential 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).

You may not qualify if:

  • 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 and 14 drinks/week for females.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

March 18, 2010

Record last verified: 2010-03

Locations

BE(1)