Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: July 16, 2010
Last updated: August 23, 2010
Last verified: August 2010
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.

Condition Intervention Phase
Drug: PF-05186462
Drug: PF-05089771
Drug: PF-05150122
Drug: PF-05241328
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability (heart rate, blood pressure, QTcF, clinical chemistry) [ Time Frame: up to 3 days post dose ]
  • 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 Outcome Measures:
  • safety and tolerability of each of the four compounds (heart rate, blood pressure, QTcF, clinical chemistry) [ Time Frame: up to 3 days post dose ]

Enrollment: 40
Study Start Date: July 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intravenous: PF-05186462 Drug: PF-05186462
single intravenous infusion of 100 microgram
Active Comparator: Oral: PF-05186462 Drug: PF-05186462
single oral administration of 100 microgram
Active Comparator: Intravenous: PF-05089771 Drug: PF-05089771
single intravenous infusion of 100 microgram of PF-05089771
Active Comparator: Oral: PF-05089771 Drug: PF-05089771
single oral administration of 100 microgram PF-05089771
Active Comparator: Intravenous: PF-05150122 Drug: PF-05150122
single intravenous administration of 100 microgram PF-05150122
Active Comparator: Oral: PF-05150122 Drug: PF-05150122
single oral administration of 100 microgram PF-05150122
Active Comparator: Intravenous: PF-05241328 Drug: PF-05241328
single intravenous infusion of 100 microgram PF-05241328
Active Comparator: Oral: PF-05241328 Drug: PF-05241328
single oral administration 100 microgram PF-05241328


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01165736

United Kingdom
Pfizer Investigational Site
Edinburgh, United Kingdom, EH14 4AP
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT01165736     History of Changes
Other Study ID Numbers: B3071001
Study First Received: July 16, 2010
Last Updated: August 23, 2010

Keywords provided by Pfizer:
Chronic Pain processed this record on April 28, 2017