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Completed

NCT Number: NCT00992342

A Phase 1 Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03893787 In Healthy Adult Volunteers

The purpose of this study is to investigate safety and toleration of multiple oral doses as well as the time course of PF-03893787 concentration in the blood following dosing by oral solution.

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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

Brussels, 1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects and females of non-childbearing potential between the ages of 18 and 55 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 21 drinks/week for males and 14 drinks/week for females.

Treatment and study plan

PF-03893787

Drug

oral solution, 5 mg, QD for 14 days

Primary outcomes

  1. Safety/toleration: Adverse events, vital signs, 12 lead ECG, blood (including creatine kinase) and urine safety tests and physical examination.

    Time frame: 22 days

Secondary outcomes

  1. Pharmacokinetic parameters: Cmax, Tmax, AUCτ, t½, accumulation ratio,

    Time frame: 22 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Multiple Oral Doses Of PF-03893787 In Healthy Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 9, 2009
Registry last updated
Mar 18, 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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