A Single Dose Study Of PF-04971729 In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00989079
First received: October 1, 2009
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

PF-04971729 is a new compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-04971729 in healthy volunteers.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: PF-04971729 or placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of PF-04971729 After Administration Of Single Escalating Oral Doses Under Fed And Fasted Conditions In Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability of PF-04971729 (assessed by physical examinations, adverse event monitoring, 12-lead ECGs, continuous cardiac monitoring over the first 8 hours after dosing, vital sign and clinical safety laboratory measurements). [ Time Frame: 3 days/dose group ] [ Designated as safety issue: Yes ]
  • Single dose pharmacokinetics of PF-04971729 (described by estimating parameters of AUCinf, AUClast, Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as data permit). [ Time Frame: 3 days/dose group ] [ Designated as safety issue: No ]
  • Cumulative urinary glucose excretion over 24 hours. [ Time Frame: 1 day/dose group ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Urinary glucose excretion profile [ Time Frame: 3 days/dose group ] [ Designated as safety issue: No ]
  • Serum glucose weighted mean [ Time Frame: 1 day/dose group ] [ Designated as safety issue: No ]
  • Inhibition of glucose reabsorption [ Time Frame: 1 day/dose group ] [ Designated as safety issue: No ]
  • Urinary recovery of PF-04971729 and, if data permits, renal clearance (CLr) of PF-04971729. [ Time Frame: 3 days/dose group ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: October 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Subjects in Cohort 1 will receive 2 single doses of PF-04971729 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-04971729 will be administered in Period 4 in the fed state.
Drug: PF-04971729 or placebo
PF-04971729 will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range of 0.3 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension/solution
Experimental: Cohort 2
Subjects in Cohort 2 will receive 2 single doses of PF-04971729 and 1 dose of placebo in a random order in Periods 1-3.
Drug: PF-04971729 or placebo
PF-04971729 will be administered as an extemporaneously prepared suspension/solution for all doses within the initially planned range of 0.3 mg to 300 mg. Correspondingly placebo doses will be administered as suspension/solution

  Eligibility

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

Inclusion Criteria:

  • Healthy male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

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)
  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: NCT00989079

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
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: NCT00989079     History of Changes
Other Study ID Numbers: B1521001
Study First Received: October 1, 2009
Last Updated: January 27, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Single Ascending Dose Study in healthy subjects

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014