Single Dose Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06291874 In Healthy Adult Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01794364
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 1.9
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06291874 in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06291874; Other: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo-Controlled, Single Dose Escalating Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-06291874 After Administration Under Fasted And Fed Conditions In Healthy Adult Subjects
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Cohort A Each subjects in Cohort A will receive 2 single doses of PF-06291874 and 1 placebo dose in random order in Periods 1-3; in addition, 1 dose of PF-06291874 will be administered in Period 4 in the fed state.	Drug: PF-06291874; PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 75 mg to 500 mg.; Other: placebo; Correspondingly, placebo doses will be administered as suspension.

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [0-72/dose]

2. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] [0-72/dose]

3. Maximum Observed Plasma Concentration (Cmax) [0-72/dose]

4. Time to Reach Maximum Observed Plasma Concentration (Tmax) [0-72/dose]

5. Plasma Decay Half-Life (t1/2) [0-72/dose]

6. Apparent Oral Clearance (CL/F) [0-72/dose]

7. Apparent Volume of Distribution (Vz/F) [0-72/dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male and/or female subjects of non childbearing potential.

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

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.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01794364
• Other Study ID Numbers: B4801009
• First Posted: Feb 18, 2013
• Last Update Posted: Apr 4, 2013
• Last Verified: Apr 1, 2013

• Keywords provided by Pfizer: T2DM; Diabetes Mellitus Type 2

Study Results

No Results Posted as of Apr 4, 2013