Bioavailability Study Of PF-06651600 In Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-06651600

• Registration Number: NCT02684760
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-12
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-14
• Last Update Posted: 2016-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1: PF-06651600	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.
Cohort 2: PF-06651600	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.
Cohort 3: PF-06651600	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.
Cohort 4: PF-06651600	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.
Cohort 5: PF-06651600	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.
Cohort 6: PF-06651600	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.

Primary Outcome Measures

Name	Time	Method
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)
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)
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

Name	Time	Method
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)
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)

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium