A Single Dose Study Of PF-04620110 In Healthy Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01166217
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 11.8

Study Details

Study Description

Brief Summary

PF-04620110 is a novel compound proposed for the treatment of Type 2 diabetes mellitus. The primary purpose of this trial is to evaluate the relative bioavailability of three different oral dose formulations of PF-04620110.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-04620110	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Cross-over, Single-dose, Open-label Study to Estimate the Relative Bioavailability of Three Different Formulations of Pf-04620110 Under Fed/Fasted Conditions in Healthy Adult Subjects
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: ABCE, ACBD, BACD, BCAE, CABE and CBAD

Drug: PF-04620110; The five treatments are: A) single dose of 5 mg immediate release tablets in the fasted state; B) single dose of 5 mg modified release osmotic capsule with a short duration of modified release 1 (MR1) in the fasted state; C) single dose of 5 mg modified release osmotic capsule with a long duration of modified release 2 (MR2) in the fasted state; D) single dose of 5 mg modified release osmotic capsule with a short duration of modified release 1 (MR1) in the fed state; E) single dose of 5 mg modified release osmotic capsule with a long duration of modified release 2 (MR2) in the fed state.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, C24hr, peak trough ratio (PTR), and half life [following each treatment]

Secondary Outcome Measures

1. Safety Endpoints: Safety and tolerability of PF 04620110 will be assessed by physical examinations, adverse event monitoring, 12 lead electrocardiograms (ECGs), vital signs, and clinical safety laboratory measurements. [before, during and following treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male and/or female subjects between the ages of 21 and 55 years

• Body Mass Index (BMI) of 17.5 to 30.5 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Singapore		Singapore	188770

Sponsors and Collaborators

• Pfizer
• Bristol-Myers Squibb

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01166217
• Other Study ID Numbers: B0961009
• First Posted: Jul 20, 2010
• Last Update Posted: Aug 20, 2010
• Last Verified: Aug 1, 2010

• Keywords provided by , ,: Single Dose Study in Healthy Subjects

Study Results

No Results Posted as of Aug 20, 2010