Bioavailability Study Of PF-06651600 In Healthy Subjects

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-06651600

Study type: Interventional

Funder types: Industry

Identifiers

NCT02684760

2015-004857-41 (EudraCT Number)

B7981003

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 6 patient groups

Cohort 1: PF-06651600

Experimental group

Description:

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.

Treatment:

Drug: PF-06651600

Cohort 2: PF-06651600

Experimental group

Description:

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.

Treatment:

Drug: PF-06651600

Cohort 3: PF-06651600

Experimental group

Description:

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.

Treatment:

Drug: PF-06651600

Cohort 4: PF-06651600

Experimental group

Description:

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.

Treatment:

Drug: PF-06651600

Cohort 5: PF-06651600

Experimental group

Description:

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.

Treatment:

Drug: PF-06651600

Cohort 6: PF-06651600

Experimental group

Description:

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.

Treatment:

Drug: PF-06651600