NCT01372163

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of PF-05190457 after administration of multiple doses to healthy volunteers and Type 2 diabetic patients and to evaluate the plasma drug concentrations after multiple doses.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Jul 2011

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

June 10, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed
18 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

May 23, 2012

Status Verified

May 1, 2012

Enrollment Period

9 months

First QC Date

June 10, 2011

Last Update Submit

May 22, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Phase 1Multiple Ascending DosesSafetyPharmacokineticsHealthy VolunteersType 2 Diabetic Patients

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse Events as a measure of safety and tolerability.

    8 weeks

Secondary Outcomes (8)

  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Area Under the Curve (AUC) and its accumulation ratio on days 1, 13, and 14, as appropriate and the data permit.

    2 weeks

  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Maximum Concentration (Cmax) on days 1, 13, and 14, as appropriate and the data permit.

    2 weeks

  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Time of Maximum concentration (Tmax) on days 1, 13, and 14, as appropriate and the data permit.

    2 weeks

  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of the Minimum Amount of concentration (Cmin) on days 13 and 14, as appropriate and the data permit.

    2 weeks

  • The single and multiple dose pharmacokinetics of PF-05190457 will be described by estimating parameters of Elimination of half-life (t ½ ) on day 14, as the data permit.

    2 weeks

  • +3 more secondary outcomes

Study Arms (7)

2 mg PF-05190457 or Placebo BID

EXPERIMENTAL
Drug: PF-05190457 or Placebo

10 mg PF-05190457 or Placebo BID

EXPERIMENTAL
Drug: PF-05190457 or Placebo

40 mg PF-05190457 or Placebo BID

EXPERIMENTAL

Dose and dose frequency may be adjusted based on emerging safety and PK data.

Drug: PF-05190457 or Placebo

150 mg PF-05190457 or Placebo BID

EXPERIMENTAL

Dose and dose frequency may be adjusted based on emerging safety and PK data.

Drug: PF-05190457 or Placebo

5 mg PF-05190457 or Placebo QD

EXPERIMENTAL

Dose and dose frequency may be adjusted based on emerging safety and PK data.

Drug: PF-05190457 or Placebo

50 mg PF-05190457 or Placebo QD

EXPERIMENTAL

Dose and dose frequency may be adjusted based on emerging safety and PK data.

Drug: PF-05190457 or Placebo

xxx mg PF-05190457 or Placebo

EXPERIMENTAL

Dose and dose frequency to be determined based on emerging safety and PK data.

Drug: PF-05190457 or Placebo

Interventions

PF-05190457 or PlaceboDRUG

Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.

2 mg PF-05190457 or Placebo BID

Eligibility Criteria

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

You may qualify if:

  • Healthy males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 30.5 kg/m\^2, and weight between 50 and 100 kg, inclusive.
  • Type 2 diabetic males and females of non-childbearing potential between ages of 18 and 55 years, BMI of 18.5 to 40.0 kg/m\^2, weight between 50 and 150 kg, and HbA1c of 7.0-10.0%, inclusive.

You may not qualify if:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • Additionally, type 2 diabetic patients who have history of diabetic complications with significant end-organ damage or pharmacologic treatment for diabetes in addition to metformin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PF-5190457

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
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2011

First Posted

June 13, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

May 23, 2012

Record last verified: 2012-05

Locations

US(1)