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OpenTrials
Completed

NCT Number: NCT00990015

A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).

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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

New Haven, Connecticut, 06511, United States

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.
  • Women need to be surgically sterile

Exclusion criteria

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

Treatment and study plan

PF-04308515

Drug

Oral solution/suspension 0.1 mg up to potentially 350 mg QD at a single dose.

Placebo

Drug

Placebo solution/suspension to match active drug QD at a single dose.

Primary outcomes

  1. To evaluate the safety, tolerability and pharmacokinetics (PK) of single-rising doses of PF-04308515

    Time frame: 1 day

  2. To characterize the pharmacodynamic (PD) effects of PF-04308515 on biomarkers

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Single-Dose Escalation Trial Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04308515 in Healthy Volunteers

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 6, 2009
Registry last updated
Feb 1, 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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