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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02684760

Enrollment

Registered

2016-02-18

Start date

2016-02-29

Completion date

2016-05-31

Last updated

2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Inflammatory Bowel Disease

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.

Interventions

DRUGPF-06651600

PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026