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NCT01351129 Clinical Trial

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

Healthy Clinical Trial

Official title:
A Phase 1, Single-Dose, Open-Label, Crossover Study To Estimate The Relative Bioavailability Of Two Controlled-Release Formulations Vs. An Immediate Release Formulation Of PF-04991532 In Healthy Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01351129
Other study ID # B2611009
Secondary ID
Status Completed
Phase Phase 1
First received May 9, 2011
Last updated July 5, 2011
Start date May 2011
Est. completion date June 2011

Study information
Verified date July 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Singapore: Singapore Health Sciences Authority (HSA)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

Intervention

Drug:
• Formulation 1
150-mg immediate release tablet (single dose)
• Formulation 2
150-mg modified release capsule, short duration (single dose)
• Formulation 3
150-mg modified release capsule, long duration (single dose)

Locations
Country Name City State
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Max observed plasma concentration (Cmax) predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose No
Secondary Time of Cmax (Tmax) predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose No
Secondary Concentration at 24 hours postdose (C24hr) 24 hrs postdose No
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