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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: PF-04620110

• Registration Number: NCT01064492
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-04
• Study First Submitted QC: 2010-02-04
• Study First Posted: 2010-02-08
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2010-03-16
• Last Update Posted: 2010-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ABC, ACB, BAC, BCA, CAB, and CBA	PF-04620110	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life, as the data permit.	following each treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium