NCT01202266

Brief Summary

The primary purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of multiple escalating oral doses of PF-05161704 in healthy volunteers

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
32

participants targeted

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

Timeline
Completed

Started Aug 2010

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

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 11, 2011

Status Verified

March 1, 2011

Enrollment Period

4 months

First QC Date

September 13, 2010

Last Update Submit

March 9, 2011

Conditions

Diabetes Mellitus, Type 2

Keywords

Multiple Ascending DosePhase 1Safety and TolerabilityPKHealthy Subjects

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring

    2 weeks

  • Pharmacokinetic Endpoints: single dose and steady state pharmacokinetics of PF-05161704 and its metabolite PF-05200145. Urinary recovery will also be assessed for PF-05161704 and PF-05200145

    2 weeks

Secondary Outcomes (2)

  • Pharmacodynamic Endpoints: Absolute value and change from Day 0 baseline in postprandial GLP-1. Postprandial plasma PYY, triglycerides and apoB48. Absolute value and change from baseline in apoB100 and VLDL

    2 weeks

  • Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight

    2 weeks

Study Arms (8)

5 mg PF-05161704 or Placebo

EXPERIMENTAL
Drug: PF-05161704 or Placebo

15 mg PF-05161704 or Placebo

EXPERIMENTAL

Planned dose: may be modified based on emerging PK and safety data.

Drug: PF-05161704 or Placebo

50 mg PF-05161704 or Placebo

EXPERIMENTAL

Planned dose: may be modified based on emerging PK and safety data.

Drug: PF-05161704 or Placebo

150 mg PF-05161704 or Placebo

EXPERIMENTAL

Planned dose: may be modified based on emerging PK and safety data.

Drug: PF-05161704 or Placebo

xx mg PF-05161704 or Placebo

EXPERIMENTAL

Planned dose and dosing regimen will be determined based on emerging PK and safety data.

Drug: PF-05161704 or Placebo

xxx mg PF-05161704 or Placebo

EXPERIMENTAL

Dose will be determined based on data from previous 5 arms.

Drug: PF-05161704 or Placebo

yy mg PF-05161704 or Placebo

EXPERIMENTAL

Dose will be determined based on data from previous 6 arms

Drug: PF-05161704 or Placebo

yyy mg PF-05161704 or Placebo

EXPERIMENTAL

Dose will be determined based on data from previous 7 arms.

Drug: PF-05161704 or Placebo

Interventions

PF-05161704 or PlaceboDRUG

PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner

5 mg PF-05161704 or Placebo

Eligibility Criteria

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

You may qualify if:

  • Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 24.5 to 35.5 kg/m2 and a total body weight \>50 kg (110 lbs.)

You may not qualify if:

  • 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).
  • Any condition possibly affecting drug absorption (e.g., gastrectomy).
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
  • History or evidence of habitual use of tobacco or nicotine containing products within 3 months of screening or positive cotinine test at screening or Day -1.

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

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
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 15, 2010

Study Start

August 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 11, 2011

Record last verified: 2011-03

Locations

US(1)