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Completed

NCT Number: NCT01854996

Relative Bioavailability With PF-05089771 Capsule Versus Oral Dispersion

This study aims to test plasma exposure to PF-05089771 with same formulation will be used for phase II trials (capsule).

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

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 between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Females must be of non-childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject or a legally acceptable representative, indicating that the subject has been informed of all pertinent aspects of the trial.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal (i.e recurrent uric nephrolithiasis), endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy)

Treatment and study plan

PF-05089771

Drug

450mg

Other names: no specified

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]

    Time frame: 48 hours

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: 48 hours

Secondary outcomes

  1. Number of Participants With Laboratory Test Values of Potential Clinical Importance

    Time frame: 48 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase I, Randomized, Single-Dose Study To Determine The Relative Bioavailability Of Capsule Vs Oral Dispersion And The Effect Of Food On The Pharmacokinetics Of Orally Administered PF-05089771 As Capsule In Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
May 16, 2013
Registry last updated
Jun 25, 2013

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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