NCT01637285

Brief Summary

The purpose of the study is to further evaluate the PK characteristics of PF-04856883.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Aug 2012

Typical duration 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

First Submitted

Initial submission to the registry

June 26, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

June 26, 2012

Last Update Submit

July 30, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2

    4 weeks

Secondary Outcomes (5)

  • Number of subjects with AEs reported

    4 weeks

  • Number of subjects with abnormal physical examination findings

    4 weeks

  • Number of subjects with abnormal clinical laboratory results

    4 weeks

  • Number of subjects with abnormal ECGs

    4 weeks

  • Number of subjects with abnormal vital signs

    4 weeks

Study Arms (4)

PF-04856883 Treatment Arm 1

EXPERIMENTAL
Biological: PF-04856883

PF-04856883 Treatment Arm 2

EXPERIMENTAL
Biological: PF-04856883

PF-04856883 Treatment Arm 3

EXPERIMENTAL
Biological: PF-04856883

PF-04856883 Treatment Arm 4

EXPERIMENTAL
Biological: PF-04856883

Interventions

PF-04856883BIOLOGICAL

Dose A

PF-04856883 Treatment Arm 1

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Haven Clinical Research Unit

New Haven, Connecticut, 06511, United States

Location

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2012

First Posted

July 11, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

US(1)