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Completed

NCT Number: NCT00812825

A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males between 18 and 55 years, inclusive.
  • Healthy females between 18 and 44 years, inclusive.

Exclusion criteria

  • Evidence or history of clinically significant disease;
  • Post-menopausal women;
  • History of intolerance or significant adverse effects with glucocorticoids. therapy.

Treatment and study plan

PF-04171327

Drug

PF-0417327 will be provided as an oral solution administered at doses of 1, 3, 10 and 30 mg. If an additional cohort is required, the dose selected will not exceed 100 mg. Solution will be administered once daily for 14 days.

Prednisolone

Drug

Oral doses of prednisolone (5, 10, and 20 mg) will be administered to the first three cohorts. The fourth cohort will receive between 1 and 20 mg to be determined after the third cohort completes dosing. If an additional cohort is required, the dose selected will not exceed 40 mg. Prednisolone tablets will be administered once daily for 14 days

Placebo

Drug

Tablets similar in appearance to prednisolone will be administered once daily for 14 days.

Placebo solution

Drug

Placebo solution will be administered to those volunteers who are randomized to the placebo or prednisolone arms. This will be administered orally each day for 14 days.

PF-04171327 Tablet

Drug

A single 10 mg dose of PF-04171327 tablet formulation will be administered orally to volunteers in Part 2 of this study.

Primary outcomes

  1. Safety and tolerability of multiple doses of PF-04171327

    Time frame: 14 days

  2. Determination of pharmacokinetic parameters of PF-04171327 after multiple doses

    Time frame: 14 days

  3. Assessment of the pharmacodynamic effects of PF-04171327 on chemical and metabolic biomarkers

    Time frame: 14 days

  4. Evaluation of the pharmacokinetic parameters of a single 10 mg dose of PF-04171327 tablet

    Time frame: 1 day

Secondary outcomes

  1. To characterize the pharmacodynamic effects of prednisolone

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Active and Placebo-Controlled, Multiple-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04171327 (Part 1), and a Single Dose Pharmacokinetic Assessment of a Tablet Formulation (Part 2) in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Aug 12, 2009

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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