Skip to main content
OpenTrials
Completed

NCT Number: NCT01247883

A Comparison Of A Single PF-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

This study investigates the safety, tolerability and pharmacokinetics of PF-04634817 when respectively given orally as a single tablet dose and a single dose of a solution.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

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 male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history and full physical examination.)
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease;
  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication;
  • Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day;
  • Nursing females;
  • Females of childbearing potential.

Treatment and study plan

PF-04634817

Drug

single dose, 20mg, tablet

Primary outcomes

  1. adverse events

    Time frame: 4 days

  2. Plasma Pharmacokinetics for both tablet and solution dosage forms.

    Time frame: 4 days

  3. The relative bioavailability (Frel) of PF-04634817 when administered as a tablet compared with a solution.

    Time frame: 4 days

  4. lab measurements

    Time frame: 4 days

  5. vitals/ECG parameters

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Incyte Corporation

Registry information

Official study title

A Two Period, 2 Sequence Crossover To Establish The Relative Bioavailability Of A Single Pf-04634817 Tablet Dose Compared With A Solution In Healthy Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 24, 2010
Registry last updated
Feb 2, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.