Bioavailability Study Of PF-06651600 In Healthy Subjects

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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