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A Radiolabeled Mass Balance Study of [14C]-PF04971729 In Healthy Male Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01127308
First received: May 19, 2010
Last updated: July 20, 2010
Last verified: July 2010
History of Changes

May 19, 2010
July 20, 2010
June 2010
July 2010   (final data collection date for primary outcome measure)
  • Mass Balance: Urinary and fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • PK parameters: AUClast, AUCinf, Cmax, Tmax and t1/2 to describe the single dose PK of a) total radioactivity in plasma; b) PF04971729 in plasma [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Metabolic Profiling/identification and determination of relative abundance of PF04971729 and the metabolites of PF04971729 in plasma, urine, and feces [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Safety endpoints including physical examinations, adverse events, clinical laboratory measurements, vital signs and ECGs. [ Time Frame: 7 Days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01127308 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Radiolabeled Mass Balance Study of [14C]-PF04971729 In Healthy Male Subjects
An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion Balance And Metabolism Of [14C]-PF04971729 In Healthy Adult Male Subjects

This is single dose study of radiolabeled [14C]-PF04971729 in healthy male volunteers to study the absorption, distribution, metabolism and elimination of PF04971729.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus (T2DM)
Drug: PF04971729
PF04971729 will be administered as oral suspension containing approximately 100 uCi of [14C]PF04971729
Experimental: [14C]PF04971729
Single dose - oral dosing suspension
Intervention: Drug: PF04971729
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Female subjects. Subjects enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01127308
B1521003
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP