NCT01513928

Brief Summary

This study is designed to compare the pharmacokinetics of three different formulations of Pf-04937319

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_1 healthy

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

Study Start

First participant enrolled

January 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2012

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

March 12, 2012

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

January 17, 2012

Last Update Submit

March 8, 2012

Conditions

Healthy

Keywords

pharmacokineticsrelative bioavailabilityformulation comparison

Outcome Measures

Primary Outcomes (10)

  • Pf-04937319: Maximum plasma concentration (Cmax)

    0 - 96 hours post dose

  • Pf-04937319: Time for Cmax (Tmax)

    0 - 96 hours post dose

  • Pf-04937319: Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (AUClast)

    0 - 96 hours post dose

  • Pf-04937319: Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf)

    0 - 96 hours post dose

  • Pf-04937319: terminal half-life (T1/2)

    0 - 96 hours post dose

  • PF-06455349: Maximum Observed Plasma Concentration (Cmax)

    0 - 96 hours post dose

  • PF-06455349: Time to Reach Maximum Observed Plasma Concentration (Tmax)

    0 - 96 hours post dose

  • PF-06455349: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    0 - 96 hours post dose

  • PF-06455349: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]

    0 - 96 hours post dose

  • PF-06455349: Plasma Decay Half-Life (t1/2)

    0 - 96 hours post dose

Interventions

Pf-04937319DRUG

Formulation A) Pf-04937319 50 mg - administered as tablet

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests.
  • Subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28-days after the last dose of treatment.
  • Body Mass Index (BMI) of 23 to 33 kg/m2 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 (excluding untreated seasonal allergies).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Interventions

N,N-dimethyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2012

First Posted

January 20, 2012

Study Start

January 1, 2012

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

March 12, 2012

Record last verified: 2012-03

Locations

SG(1)