AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

A 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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02163161

Enrollment

Registered

2014-06-13

Start date

2014-06-30

Completion date

2014-08-31

Last updated

2014-08-18

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

Conditions

Healthy

Keywords

Phase I, Open Label, Single dose, Crossover, Bioavailability, Fasting, Fed, PF-04965842, Healthy

Brief summary

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.

Interventions

DRUGPF-04965842

Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions

DRUGPF- 04965842

Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions

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 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.

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve from Time Zero to infinity (AUC inf)	15 days	—
Maximum Observed Plasma Concentration (Cmax)	15 days	—
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	15 days	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Secondary

Measure	Time frame	Description
Time to Reach Maximum Observed Plasma Concentration (Tmax)	15 days	—
Plasma Decay Half-Life (t1/2)	15 days	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026