Bioavailability Study Of PF-06651600 In Healthy Subjects

A Phase 1, Open Label, Single-dose 3-way Crossover Study To Evaluate The Relative Bioavailability Of A Solid Dose Formulation Of Pf-06651600 Under Fasting Conditions And The Effect Of A High Fat Meal On The Bioavailability Of The Solid Dosage Formulation Of Pf-06651600 In Healthy Subjects

PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PF-06651600

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male/female subjects between 18 and 55 years old, inclusive. Females must be of non-child bearing potential.
• BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• Prior history of chicken pox.
• Evidence of personally signed and dated informed consent document.
• Willing and able to comply with scheduled visits, treatment plan, lab tests and other study procedures.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, GI, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
• History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males.
• Screening blood pressure >140/90 mm Hg.
• Screening laboratory abnormalities as defined by the protocol.
• Unwilling or unable to comply with the Lifestyle Guidelines as defined by the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1: PF-06651600; Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.	Drug: PF-06651600; PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
EXPERIMENTAL: Cohort 2: PF-06651600; Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.	Drug: PF-06651600; PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
EXPERIMENTAL: Cohort 3: PF-06651600; Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.	Drug: PF-06651600; PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
EXPERIMENTAL: Cohort 4: PF-06651600; Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.	Drug: PF-06651600; PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
EXPERIMENTAL: Cohort 5: PF-06651600; Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.	Drug: PF-06651600; PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
EXPERIMENTAL: Cohort 6: PF-06651600; Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability.	Drug: PF-06651600; PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600	Time to Reach Maximum Observed Plasma Concentration (Cmax)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Decay Half Life (t1/2) for PF-06651600	Plasma Decay Half-Life (t1/2)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Time to Reach Maximum Concentration (Tmax) for PF-06651600	Time to Reach Maximum Concentration (Tmax)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): May 1, 2016

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (ESTIMATE): February 18, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 16, 2016
• Last Update Submitted That Met QC Criteria: June 14, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease
• Other Study ID Numbers: B7981003; 2015-004857-41 (EUDRACT_NUMBER)