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Completed

NCT Number: NCT00756743

Multiple Dose Safety Study of PF-04802540 in Healthy Volunteers

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.

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Key information

Conditions

Healthy

Age range

21 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Singapore, 188770

About this study

Evaluation of safety and pharmacokinetics

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

PF-04802540

Drug

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

Placebo

Drug

Placebo capsules q12 hours for 10 days

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

Sponsors and collaborators

Lead sponsor

Taisho Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase I Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-04802540 After Multiple Oral Dose Administration To Healthy Adult Volunteers

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2008
Registry last updated
Mar 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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