NCT01217918

Brief Summary

Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

2 active sites

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

October 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 15, 2011

Status Verified

February 1, 2011

Enrollment Period

4 months

First QC Date

October 7, 2010

Last Update Submit

February 14, 2011

Conditions

Healthy

Keywords

PH-797804JapanesePhase 1multiple dose study

Outcome Measures

Primary Outcomes (4)

  • Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.

    Day 1 to Follow-up

  • Mean change from baseline in vital signs (blood pressure and heart rate) measurements

    Baseline to Follow-up

  • Mean change from baseline in 12-lead ECG parameters

    Baseline to Follow-up

  • Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax

    Days 1 and 10

Study Arms (3)

Cohort 1

EXPERIMENTAL

PH-797804

Drug: 1 mg

Cohort 2

EXPERIMENTAL

PH-797804

Drug: 5 mg

Cohotr 3

EXPERIMENTAL

PH-797804

Drug: 10 mg

Interventions

1 mgDRUG

1 mg or placebo a material sparing tablet per day for 10 days

Cohort 1
5 mgDRUG

5 mg or placebo as material sparing tablet per day for 10 days

Cohort 2
10 mgDRUG

10 mg or placebo as a material sparing tablet per day for 10 days

Cohotr 3

Eligibility Criteria

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

You may qualify if:

  • Healthy Volunteers
  • Japanese

You may not qualify if:

  • Subjects with clinically significant skin lesions
  • Subjects with known tuberculosis infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Culver City, California, 90232, United States

Location

Pfizer Investigational Site

Glendale, California, 91206, United States

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 7, 2010

First Posted

October 8, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 15, 2011

Record last verified: 2011-02

Locations

US(2)