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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01165736
First received: July 16, 2010
Last updated: August 23, 2010
Last verified: August 2010
  Purpose

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
Healthy
Drug: PF-05186462
Drug: PF-05089771
Drug: PF-05150122
Drug: PF-05241328
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01165736

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

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01165736     History of Changes
Other Study ID Numbers: B3071001
Study First Received: July 16, 2010
Last Updated: August 23, 2010
Health Authority: United Kingdom: European Medicines Evaluation Agency

Keywords provided by Pfizer:
pharmacokinetics
safety
tolerability
Chronic Pain

ClinicalTrials.gov processed this record on October 21, 2014