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NCT Number: NCT01165736

To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity

The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.

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Key information

Conditions

Healthy Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Edinburgh, EH14 4AP, 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 50 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)
  • Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion criteria

  • Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
  • History of febrile illness within 5 days prior to the first dose a positive urine drug screen

Treatment and study plan

PF-05186462

Drug

single intravenous infusion of 100 microgram

PF-05089771

Drug

single intravenous infusion of 100 microgram of PF-05089771

PF-05150122

Drug

single intravenous administration of 100 microgram PF-05150122

PF-05241328

Drug

single intravenous infusion of 100 microgram PF-05241328

Primary outcomes

  1. Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry)

    Time frame: up to 3 days post dose

  2. pharmacokinetics of each of the four compounds measuring Clearance, volume of distribution, elimination half life and area under the effect curve

    Time frame: up to 3 days post dose

Secondary outcomes

  1. safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry)

    Time frame: up to 3 days post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Exploratory, Open Label, Randomized, Parallel Group Study To Investigate The Pharmacokinetics Of Single Intravenous And Oral Micro Doses Of PF-05186462, PF-05089771, PF-05241328 And PF-05150122 In Healthy Male Subjects

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 20, 2010
Registry last updated
Aug 24, 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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