Bioavailability Study Of PF-06651600 In Healthy Subjects

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684760
• Other study ID #: B7981003
• Secondary ID: 2015-004857-41
• Status: Completed
• Phase: Phase 1
• First received: February 12, 2016
• Last updated: June 14, 2016
• Start date: February 2016
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600	Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Primary	Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600	Time to Reach Maximum Observed Plasma Concentration (Cmax)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Plasma Decay Half Life (t1/2) for PF-06651600	Plasma Decay Half-Life (t1/2)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No
Secondary	Time to Reach Maximum Concentration (Tmax) for PF-06651600	Time to Reach Maximum Concentration (Tmax)	0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose	No

External Links

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