Single Dose Study of PF-04991532 in Healthy Subjects

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Phase 1 Placebo-Controlled Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Food Effect of Single Escalating Oral Doses of PF-04991532 in Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102673
• Other study ID #: B2611001
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2010
• Last updated: August 3, 2010
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: August 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Safety/Tolerability and PK

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Drug:
• 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.
• Placebo
Placebo to match PF-04991532 will be provided

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability Endpoints: physical exams, AE monitoring, 12-lead ECGs, continuous cardiac monitoring, vital sign and clinical safety laboratory (including frequent glucose assessments via glucometer) measurements.		1 month	Yes
Primary	PK Endpoints: AUC(0-inf), AUC(0-last), AUC(0-24), Cmax, Tmax, CL/F, Vz/F and half-life (t1/2), as the data permit.		1 month	No
Secondary	none-see my comment			No

External Links

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