AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04965842; Drug: PF- 04965842

• Registration Number: NCT02163161
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	PF-04965842	-
Treatment C	PF- 04965842	-
Treatment B	PF-04965842	-

Primary Outcome Measures

Name	Time	Method
Area Under the Curve from Time Zero to infinity (AUC inf)	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)
Maximum Observed Plasma Concentration (Cmax)	15 days

Secondary Outcome Measures

Name	Time	Method
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.
Time to Reach Maximum Observed Plasma Concentration (Tmax)	15 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Brussels, Belgium