AStudy to Evaluate the Bioavailability of PF 04965842 in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02163161
• Other study ID #: B7451004
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2014
• Last updated: August 15, 2014
• Start date: June 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-04965842
Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions
• PF-04965842
Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions
• PF- 04965842
Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve from Time Zero to infinity (AUC inf)		15 days	No
Primary	Maximum Observed Plasma Concentration (Cmax)		15 days	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	15 days	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		15 days	No
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	15 days	No

External Links

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