Bioavailability Study Of PF-06651600 In Healthy Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02684760
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 6
• Duration (Months): 3
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-06651600	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 [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 Extrapolated Infinite Time (AUCinf)

2. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600 [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)

3. Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 [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)

Secondary Outcome Measures

1. Plasma Decay Half Life (t1/2) for PF-06651600 [0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose]

   Plasma Decay Half-Life (t1/2)

2. Time to Reach Maximum Concentration (Tmax) for PF-06651600 [0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose]

   Time to Reach Maximum Concentration (Tmax)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Clinical Research Unit	Brussels		Belgium	1070

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02684760
• Other Study ID Numbers: B7981003; 2015-004857-41
• First Posted: Feb 18, 2016
• Last Update Posted: Jun 16, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Pfizer: Inflammatory Bowel Disease

Study Results

No Results Posted as of Jun 16, 2016