You are here

Our science / Clinical Trials / Find a Trial / NCT01082380

Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers

Back to Search Print Save as PDF Bookmark Trial

NCT01082380

Last updated on November 14, 2019
Back to Search Print Save as PDF Bookmark Trial

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
measurement, 12 lead ECG and clinical laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110
lbs).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

- Any condition possibly affecting drug absorption (eg, gastrectomy).

- A positive urine drug screen.

NCT01082380
Pfizer
Completed
Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Advanced Search

Based on your search, you may also be interested in

Hepatic Impairment, Healthy Volunteers
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
NCT04091061
All Genders
18+
Years
Multiple Sites
Healthy Volunteers
A Study of PF-06651600 Effect on Rosuvastatin Pharmacokinetics in Healthy Participants
NCT04092595
All Genders
18+
Years
Brussels, Be-bru
Adult, Drug Interactions, Healthy Volunteers, Humans
Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants
NCT03961997
All Genders
18+
Years
Brussels, Be-bru
Healthy Volunteers
A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects
NCT03162900
All Genders
18+
Years
Brussels,
Descriptive Information
Brief Title  ICMJE Radiolabeled [14C]PF-02341066 Study To Investigate The Absorption, Metabolism And Excretion In Healthy Male Volunteers
Official Title  ICMJE A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C]PF-02341066 In Healthy Male Volunteers
Brief SummaryThe rationale for this study is to investigate the absorption, metabolism and excretion of [14C]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any metabolites, if possible, of [14C]PF 02341066 in humans.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE Drug: PF-02341066
oral suspension, single 250 mg dose of PF 02341066 containing approximately 100 µCi of [14C]PF 02341066
Other Name: crizotinib
Study Arms  ICMJE Experimental: 1
Intervention: Drug: PF-02341066
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 5, 2010)		6
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion DateApril 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 measurement, 12 lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; 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).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01082380
Other Study ID Numbers  ICMJE A8081009
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now