A Study to Assess the Relative Bioavailability of a Modified-Release Formulation of PF-05180999

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-05180999

Study type: Interventional

Funder types: Industry

Identifiers

NCT01530529

B3441007

Details and patient eligibility

About

The purpose of this study is to assess the bioavailability, safety, and tolerability of a modified-release formulation of PF-05180999 relative to an immediate-release formulation in healthy adult subjects. Two doses of the modified-release formulation and one dose of the immediate-release formulation will be evaluated under fasted conditions. One dose of the modified-release formulation will also be evaluated in the presence of food.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female of non-childbearing potential

Exclusion criteria

• Evidence of clinically-significant medical illness, history of seizures, any condition possibly affecting drug absorption

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

PF-05180999 Immediate-Release

Experimental group

Treatment:

Drug: PF-05180999

Drug: PF-05180999

Drug: PF-05180999

Drug: PF-05180999

PF-05180999 Modified-Release 1

Experimental group

Treatment:

Drug: PF-05180999

Drug: PF-05180999

Drug: PF-05180999

Drug: PF-05180999

PF-05180999 Modified-Release 2

Experimental group

Treatment:

Drug: PF-05180999

Drug: PF-05180999

Drug: PF-05180999

Drug: PF-05180999

PF-05180999 Modified-Release 1 With Food

Experimental group

Treatment:

Drug: PF-05180999

Drug: PF-05180999

Drug: PF-05180999

Drug: PF-05180999