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Completed

NCT Number: NCT01408355

A Study To Investigate The Elimination Of PF-06273588 From The Body Following A Single Low Dose.

To investigate the pharmacokinetics of PF-06273588 following administration of a micro-dose via both intravenous and oral routes.

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 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 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 measurements, 12-lead ECG and clinical laboratory tests.
  • 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 (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.

Treatment and study plan

PF-06273588

Drug

Intravenous, 50 microgram, single dose

Primary outcomes

  1. The number of participants with Adverse Events as a measure of Safety and tolerability.

    Time frame: 3 days

  2. Pharmacokinetics : peak plasma concentration

    Time frame: 3 days

  3. Pharmacokinetics : time of peak plasma concentration

    Time frame: 3 days

  4. Pharmacokinetics : area under plasma concentration-time curve

    Time frame: 3 days

  5. Pharmacokinetics : Terminal plasma half life

    Time frame: 3 days

  6. Pharmacokinetics : Plasma Clearance

    Time frame: 3 days

  7. Pharmacokinetics : plasma volume of distribution

    Time frame: 3 days

  8. Pharmacokinetics : oral bioavailability

    Time frame: 3 days

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Exploratory, Open Label, Fixed Sequence Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-06273588 In Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 3, 2011
Registry last updated
Sep 9, 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.

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