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Completed

NCT Number: NCT02142920

Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers

The purpose of the study is to characterize how PF-05212384 is metabolized in the body following a single intravenous dose of radioactively labeled drug ([14C]-PF-05212384).

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Key information

Conditions

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Ruddington Fields, Nottingham, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects between the ages of 30- 65 years vasectomised or >40 with no desire to father children in the near future (12 months), 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).
  • Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight >50 kg (110 lbs).
  • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
  • Subjects agree to use an adequate method of contraception

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 or history of drug or alcohol abuse in the past 2 years.

Treatment and study plan

PF-05212384

Drug

Single 89 mg Dose via 30 minute IV infusion

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: 0.5 hours

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

    Time frame: 0.5 hours

Secondary outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 9 Days

    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  2. Area under the Concentration-Time Curve (AUC)

    Time frame: 9 days

    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.

  3. Plasma Decay Half-Life (t1/2)

    Time frame: 9 days

    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  4. Systemic Clearance (CL)

    Time frame: 9 days

    CL is a quantitative measure of the rate at which a drug substance is removed from the body.

  5. Volume of Distribution at Steady State (Vss)

    Time frame: 9 days

    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase One, Open-Label Single-Radiolabeled Dose Study To Investigate The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 20, 2014
Registry last updated
Sep 4, 2014

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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