Bioequivalence Study of PF-06651600 Capsules Relative to Tablets and Estimation of Food Effect on Capsules.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: PF-06651600

Study type: Interventional

Funder types: Industry

Identifiers

NCT04390776

B7981029

Details and patient eligibility

About

The study will be conducted as a Phase 1, open-label, single-dose, randomized, 2- or 3 period, cross over design in a single cohort.

Enrollment: 164 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes BP and pulse rate measurement, clinical laboratory tests, and cardiac evaluation (including ECG).
• BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine (including diabetes), pulmonary, gastrointestinal, cardiovascular (including hypertension and congestive heart failure), hepatic, psychiatric, neurological, dermatological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
• Known immunodeficiency disorder, including positive serology for human immunodeficiency virus (HIV) at screening, or a first degree relative with a hereditary immunodeficiency.

Participants with any of the following acute or chronic infections or infection history:

• Any infection requiring treatment within 2 weeks prior to the dosing visit.
• Any infection requiring hospitalization or parenteral antimicrobial therapy within 60 days of the first dose of study intervention.
• Any infection judged to be an opportunistic infection or clinically significant by the investigator, within the past 6 months of the first dose of study intervention.
• Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
• History of recurrent (more than one episode of) localized dermatomal herpes zoster, or history of disseminated (single episode) herpes simplex or disseminated herpes zoster.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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164 participants in 4 patient groups

Treatment Sequence 1

Experimental group

Description:

PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2), and followed by Capsules (fed, Period 3).

Treatment:

Drug: PF-06651600

Treatment Sequence 2

Experimental group

Description:

PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2), and followed by Capsules (fed, Period 3).

Treatment:

Drug: PF-06651600

Treatment Sequence 3

Experimental group

Description:

PF-06651600 100 mg Tablets (fasted, Period 1), followed by Capsules (fasted, Period 2).

Treatment:

Drug: PF-06651600

Treatment Sequence 4

Experimental group

Description:

PF-06651600 100 mg Capsules (fasted, Period 1), followed by Tablets (fasted, Period 2).

Treatment:

Drug: PF-06651600