The Bioavailability of a Spray Dried Dispersion Solid Dose Formulation of PF-06260414 Relative to a Suspension Formulation

Pfizer

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06260414 nanosuspension; Drug: PF 06260414 solid dose formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02393807

SARM FOOD EFFECT &BE (Other Identifier)

SARM FOOD EFFECT & BE (Other Identifier)

B7411002

Details and patient eligibility

About

The current study will investigate the relative bioavailability of a spray dried dispersion solid dose formulation of PF 06260414 administered as a single oral dose of 30 mg of PF 06260414 relative to a single oral dose of 30 mg of PF 06260414 administered as a nanosuspension under fasted or fed conditions in healthy adult subjects.

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
• Any condition possibly affecting drug absorption (eg, gastrectomy)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Open label single dose crossover study of PF-06260414

Experimental group

Description:

This will be a Phase 1, open label, randomized, single dose, 3 period, 3 way crossover study to evaluate the relative bioavailability of solid dose formulation of PF 06260414 under fasted conditions compared to the nanosuspension under fasted conditions

Treatment:

Drug: PF-06260414 nanosuspension

Drug: PF 06260414 solid dose formulation