A Phase 1 Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability And Food Effect Of PF-04620110 In Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064492
• Other study ID #: B0961004
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2010
• Last updated: March 16, 2010
• Start date: February 2010
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial Summary

PF 04620110 is an acylCoA:diacylglycerol acyltransferase 1 (DGAT1) inhibitor that is being developed for the treatment of type 2 diabetes mellitus (T2DM). It is anticipated that PF 04620110 will have anti diabetic effects through inhibition of intestinal triglyceride absorption and potentially weight loss. The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple oral formulations of PF 04620110 administered to healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female 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).

• Women must be of non childbearing potential.

• 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 (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.

• Any condition possibly affecting drug absorption (eg, gastrectomy).

• A positive urine drug screen.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• PF-04620110
The three treatments are A) a single dose of 5 mg PIC under fasted condition; B) a single dose of 5 mg tablet under fasted condition: and C) a single dose of 5 mg tablet under fed condition.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life, as the data permit.		following each treatment	No
Secondary	Safety Endpoints: Safety and tolerability of PF 04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead ECGs, vital sign, and clinical safety laboratory measurements.		before, during, and following treatment	No

External Links

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