Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

A Phase 1, Single-Dose, Open-Label, Crossover Study To Assess The Relative Bioavailability Of 2 Different Formulations Of PF-04991532

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01388829

Enrollment

Registered

2011-07-07

Start date

2011-07-31

Completion date

2011-08-31

Last updated

2011-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

formulation comparison

Brief summary

This study is designed to compare the pharmacokinetics of two different lots of tablets.

Interventions

DRUGTreatment A

150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R3 lot

DRUGTreatment B

150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R4 lot

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and/or female (non childbearing potential) 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 as defined in Lifestyle Guidelines. * 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 or a legally acceptable representative.

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. * Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement \[confirmed by a single repeat, if necessary\] following at least 5 minutes of rest. * Any condition possibly affecting drug absorption (eg, gastrectomy).

Design outcomes

Primary

Measure	Time frame
Plasma AUClast	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours
Plasma Cmax	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours

Secondary

Measure	Time frame
Plasma Tmax	0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026