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CompletedNCT00756743Updated Mar 19, 2010

Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

A Phase 1 interventional study of PF-04802540 and Placebo in Healthy, sponsored by Taisho Pharmaceutical Co., Ltd.. Completed at 1 site in Singapore. Open to participants aged 21 Years to 54 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-03-19.

Sponsored by Taisho Pharmaceutical Co., Ltd. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
21 Years to 54 Years
Sex
All
01

Study 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.

Read the detailed description

Evaluation of safety and pharmacokinetics

02

Conditions studied

  • Healthy

Keywords

  • PF-04802540 multiple dose safety study
03

In context

Lead sponsor

Taisho Pharmaceutical Co., Ltd. is the lead sponsor of 41 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 54 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Use of prescription or nonprescription drugs
  • Any condition possibly affecting drug absorption
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    PF-04802540

    Drug: PF-04802540

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugPF-04802540

    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

  • DrugPlacebo

    Placebo capsules q12 hours for 10 days

06

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: 12 days

  2. Safety assessments: vital signs, ECG, physical examination, laboratory tests

    Time frame: 12 days

  3. Pharmacokinetics

    Time frame: 12 days

Secondary outcomes

  1. No secondary outcomes measures.

    Time frame: Timeframe N/A

07

Study locations

1 site
  • Pfizer Investigational Site
    Singapore, 188770, Singapore
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00756743
Lead sponsor
Taisho Pharmaceutical Co., Ltd.
First posted
Sep 22, 2008
Start date
Sep 2008
Primary completion
Jan 2009
Completion
Jan 2009
Last update
Mar 19, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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