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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 1, 2009

Last Updated Date

January 27, 2010

Start Date ^ICMJE

October 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00989079 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Single Dose Study Of PF-04971729 In Healthy Volunteers

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

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
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

Study Arm (s)

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.

Intervention: Drug: PF-04971729 or placebo
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.

Intervention: Drug: PF-04971729 or placebo

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

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00989079

Other Study ID Numbers ^ICMJE

B1521001

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2010

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

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