Single Dose Study To Compare Pharmacokinietics Of 3 Different Formulations Of PF-04991532 In Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Formulation 3; Drug: Formulation 2; Drug: Formulation 1

• Registration Number: NCT01351129
• Lead Sponsor: Pfizer

Brief Summary

The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-09
• Study First Posted: 2011-05-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-05
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

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

Inclusion Criteria

• Healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• An informed consent document signed and dated by the subject.

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
Formulation 3	Formulation 3	-
Formulation 2	Formulation 2	-
Formulation 1	Formulation 1	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time profile (AUC)	predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

Secondary Outcome Measures

Name	Time	Method
Time of Cmax (Tmax)	predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Concentration at 24 hours postdose (C24hr)	24 hrs postdose
Max observed plasma concentration (Cmax)	predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore