NCT00797342

Brief Summary

This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04629991 in healthy subjects. Dose exploration will proceed in a step-wise manner, beginning with low doses not expected to have significant biological effects and proceeding to doses approximating or exceeding the anticipated therapeutic level. Doses to be explored may be limited by tolerability, and will not exceed levels previously shown to be tolerable in animals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2008

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

November 19, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

4 months

First QC Date

November 19, 2008

Last Update Submit

May 1, 2009

Conditions

Healthy Volunteers

Keywords

rheumatoid arthritis First in human safety pharmacokinetics pharmacodynamics

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetics e.g., maximum concentration and area under the concentration-time curve

    2 weeks

  • Safety/Tolerability e.g., reported adverse events and safety laboratory studies

    2 weeks

  • Pharmacodynamics e.g., changes in a peripheral blood biomarker

    2 weeks

Study Arms (3)

first of three dosing cohorts

OTHER
Drug: PF-04629991

second of three dosing cohorts

OTHER
Drug: PF-04629991

third of three dosing cohorts

OTHER
Drug: PF-04629991

Interventions

PF-04629991DRUG

Oral; Sequential single dose escalation; three fourteen-day treatment periods per subject in the first cohort; randomized sequence of treatments (one placebo and two PF-04629991 doses)

first of three dosing cohorts

Eligibility Criteria

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

You may qualify if:

  • Healthy non-smoking men and women
  • body mass index 18-30 kg/m2

You may not qualify if:

  • Women must not be able to have children
  • no current infections

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
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 19, 2008

First Posted

November 25, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

BE(1)