NCT01366287

Brief Summary

The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical studies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2011

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
Last Updated

June 6, 2011

Status Verified

June 1, 2011

Enrollment Period

1 month

First QC Date

January 4, 2011

Last Update Submit

June 2, 2011

Conditions

Diabetes Mellitus, Type 2

Keywords

Relative bioavailabilityfood effecttabletsuspensionsingle dosecrossoverhealthy subjects

Outcome Measures

Primary Outcomes (2)

  • PF-03882845 PK: Cmax, AUCinf, AUClast, Tmax, t1/2, as data permit.

    Post dose is measured at 24, 48 and 96 hours after dose.

    predose and post each dose (24, 48 and 96 hour timepoints)

  • Safety: Safety labs, vital signs, ECGs, physical examinations and adverse event monitoring.

    45 days

Study Arms (3)

Suspension/fasted

EXPERIMENTAL
Drug: PF-03882845

Tablet/fasted

EXPERIMENTAL
Drug: PF-03882845

Tablet/fed

EXPERIMENTAL
Drug: PF-03882845

Interventions

PF-03882845DRUG

25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition

Suspension/fasted

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between the ages of 18 and 55 years,Females must be of non-childbearing potential. Body mass index of 17.5 to 30.5 kg/m2.
  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

  • Serum potassium \>5 mEq/L at screening.
  • Impaired kidney function (estimated GFR \<60 mL/min/1.73 m2). History of sensitivity to eplerenone, spironolactone, or related compounds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

(3S,3aR)-2-(3-chloro-4-cyanophenyl)-3-cyclopentyl-3,3a,4,5-tetrahydro-2H-benzo(g)indazole-7-carboxylic acid

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2011

First Posted

June 6, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

June 6, 2011

Record last verified: 2011-06

Locations

BE(1)