AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF- 04965842; Drug: PF-04965842

Study type: Interventional

Funder types: Industry

Identifiers

NCT02163161

B7451004

Details and patient eligibility

About

Phase 1, open label, single dose, 3 way crossover study to evaluate the bioavailability of a solid dose formulation of PF 04965842 relative to a suspension formulation under fasting conditions and the effect of food on the bioavailability of the solid dosage formulation of PF 04965842 in healthy subjects.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects and female subjects of non childbearing potential between the ages of 18 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).

Exclusion criteria

• Subjects who received within 7 days prior to the first dose of study medication or are likely to receive during the study any moderate strong inhibitors of CYP3A4, eg, itraconazole, erythromycin, ketoconazole, protease inhibitors, verapamil, or diltiazem.
• Subjects who received within 28 days or are likely to receive during the study inducers of CYP3A4, eg rifampin.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Treatment A

Experimental group

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Treatment B

Experimental group

Treatment:

Drug: PF-04965842

Drug: PF-04965842

Treatment C

Experimental group

Treatment:

Drug: PF- 04965842