NCT00756743

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of PF-04802540 administered orally to healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

March 19, 2010

Status Verified

January 1, 2009

Enrollment Period

4 months

First QC Date

September 19, 2008

Last Update Submit

March 17, 2010

Conditions

Healthy

Keywords

PF-04802540 multiple dose safety study

Outcome Measures

Primary Outcomes (3)

  • Adverse events

    12 days

  • Safety assessments: vital signs, ECG, physical examination, laboratory tests

    12 days

  • Pharmacokinetics

    12 days

Secondary Outcomes (1)

  • No secondary outcomes measures.

    Timeframe N/A

Study Arms (2)

PF-04802540

EXPERIMENTAL
Drug: PF-04802540

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04802540DRUG

Multiple ascending doses for 10 days; planned doses include 5, 10 and 15 mg capsules q12 hours, doses may be adjusted based on accumulating data

PF-04802540
PlaceboDRUG

Placebo capsules q12 hours for 10 days

Placebo

Eligibility Criteria

Age21 Years - 54 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males or females of non-childbearing capacity aged 21 to 55 years inclusive at screening.
  • Body mass index in the range of 18 to 30 kg/m2 and body weight\>45 kg.
  • Healthy as determined by the investigator on the basis of screening evaluation.

You may not qualify if:

  • Use of prescription or nonprescription drugs
  • Any condition possibly affecting drug absorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, 188770, Singapore

Location

Related Links

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

March 19, 2010

Record last verified: 2009-01

Locations

SG(1)