A Multiple Dose Study Of PF-05161704 In Healthy Volunteers

This study has been terminated.
(The study was terminated on October 29, 2010 due to gastrointestinal adverse events.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01202266
First received: September 13, 2010
Last updated: March 9, 2011
Last verified: March 2011
  Purpose

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


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: PF-05161704 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Phase 1 Placebo-Controlled Study To Assess The Safety, Tolerability And Pharmacokinetics Of Pf-05161704 After Administration Of Multiple Escalating Oral Doses In Healthy Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability endpoints evaluated by adverse event monitoring, laboratory values, cardiovascular monitoring [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 5 mg PF-05161704 or Placebo Drug: PF-05161704 or Placebo
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
Experimental: 15 mg PF-05161704 or Placebo
Planned dose: may be modified based on emerging PK and safety data.
Drug: PF-05161704 or Placebo
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
Experimental: 50 mg PF-05161704 or Placebo
Planned dose: may be modified based on emerging PK and safety data.
Drug: PF-05161704 or Placebo
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
Experimental: 150 mg PF-05161704 or Placebo
Planned dose: may be modified based on emerging PK and safety data.
Drug: PF-05161704 or Placebo
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
Experimental: xx mg PF-05161704 or Placebo
Planned dose and dosing regimen will be determined based on emerging PK and safety data.
Drug: PF-05161704 or Placebo
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast
Experimental: xxx mg PF-05161704 or Placebo
Dose will be determined based on data from previous 5 arms.
Drug: PF-05161704 or Placebo
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
Experimental: yy mg PF-05161704 or Placebo
Dose will be determined based on data from previous 6 arms
Drug: PF-05161704 or Placebo
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
Experimental: yyy mg PF-05161704 or Placebo
Dose will be determined based on data from previous 7 arms.
Drug: PF-05161704 or Placebo
PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast

  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 (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.)

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).
  • 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.
  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: NCT01202266

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: NCT01202266     History of Changes
Other Study ID Numbers: B2911002
Study First Received: September 13, 2010
Last Updated: March 9, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Multiple Ascending Dose
Phase 1
Safety and Tolerability
PK
Healthy Subjects

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

ClinicalTrials.gov processed this record on September 16, 2014