A Multiple Dose Study Of PF-05161704 In Healthy Volunteers

Phase 1

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: PF-05161704 or Placebo

• Registration Number: NCT01202266
• Lead Sponsor: Pfizer

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-15
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-09
• Last Update Posted: 2011-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
150 mg PF-05161704 or Placebo	PF-05161704 or Placebo	Planned dose: may be modified based on emerging PK and safety data.
yy mg PF-05161704 or Placebo	PF-05161704 or Placebo	Dose will be determined based on data from previous 6 arms
xx mg PF-05161704 or Placebo	PF-05161704 or Placebo	Planned dose and dosing regimen will be determined based on emerging PK and safety data.
15 mg PF-05161704 or Placebo	PF-05161704 or Placebo	Planned dose: may be modified based on emerging PK and safety data.
50 mg PF-05161704 or Placebo	PF-05161704 or Placebo	Planned dose: may be modified based on emerging PK and safety data.
5 mg PF-05161704 or Placebo	PF-05161704 or Placebo	-
xxx mg PF-05161704 or Placebo	PF-05161704 or Placebo	Dose will be determined based on data from previous 5 arms.
yyy mg PF-05161704 or Placebo	PF-05161704 or Placebo	Dose will be determined based on data from previous 7 arms.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Exploratory Parameters: absolute value and change from Day 0 baseline in concentrations of fasting serum lipids and body weight	2 weeks
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States