Single Dose Study of PF-04991532 in Healthy Subjects

NCT ID: NCT01102673

Last Updated: 2010-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-06-30

Brief Summary

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK) and preliminary food effect of PF-04991532 following single escalating oral doses in healthy adult subjects.

Detailed Description

Safety/Tolerability and PK

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: DOUBLE

Study Groups

PF-04991532

This will be a crossover study with 2 cohorts and an interleaving design with placebo substitution. The study will be conducted over 4 treatment periods in Cohort 1 (n=9) and over 3 treatment periods in Cohort 2 (n=9). Six subjects will be allocated to receive PF-04991532 and three subjects will be allocated to receive placebo treatment during each dosing period, except for the 4th period of Cohort 1. The 4th period of Cohort 1 will be dedicated to assess the effect of food on PF-04991532 PK parameters at one of the doses previously tested in Cohort 1; hence all 9 subjects will be dosed with PF-04991532 in an open-label fashion. A washout period of at least 7 days will occur between each dose.

Group Type: EXPERIMENTAL

PF-04991532

Intervention Type: DRUG

The tentative dosing schedule is 30, 100, 300, 600, 1200, and 2000 mg. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as extemporaneously-prepared powder in capsule (PIC) formulation.

Placebo

This will be a crossover study with 2 cohorts and an interleaving design with placebo substitution. The study will be conducted over 4 treatment periods in Cohort 1 (n=9) and over 3 treatment periods in Cohort 2 (n=9). Six subjects will be allocated to receive PF-04991532 and three subjects will be allocated to receive placebo treatment during each dosing period, except for the 4th period of Cohort 1. The 4th period of Cohort 1 will be dedicated to assess the effect of food on PF-04991532 PK parameters at one of the doses previously tested in Cohort 1; hence all 9 subjects will be dosed with PF-04991532 in an open-label fashion. A washout period of at least 7 days will occur between each dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match PF-04991532 will be provided

Interventions

PF-04991532

The tentative dosing schedule is 30, 100, 300, 600, 1200, and 2000 mg. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as extemporaneously-prepared powder in capsule (PIC) formulation.

Intervention Type: DRUG

Placebo

Placebo to match PF-04991532 will be provided

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and/or female (non child-bearing potential) subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
• Body Mass Index (BMI) of 17.5 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 (eg, 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.
• Use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.
• Self-reported history of hypoglycemia, or fasting laboratory glucose value </=80 mg/dL at screening or Day 0 of Period 1, confirmed by a single repeat if deemed necessary.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Pfizer, Inc.

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Pfizer Investigational Site

New Haven, Connecticut, United States

Countries

United States

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2611001&StudyName=Single%20Dose%20Study%20of%20PF-04991532%20in%20Healthy%20Subjects

To obtain contact information for a study center near you, click here.

Other Identifiers

B2611001

Identifier Type: -

Identifier Source: org_study_id