PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS

A SINGLE CENTER, OPEN LABEL, SINGLE ARM STUDY TO INVESTIGATE THE REPEATED DOSE (FOR 10 DAYS) PHARMACOKINETICS AFTER ORAL ADMINISTRATION OF 200 MG PF-06651600 IN CHINESE HEALTHY ADULT PARTICIPANTS

This is an open label, single arm study in healthy Chinese male and/or female adult participants. Approximately 9 participants total are planned to participate in this study to ensure that a total of 8 evaluable participants (with all primary PK parameters) can complete the study.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: PF-06651600

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100089
    • North District of Peking University Third Hospital
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Only females of non-childbearing potential
• Male and female Chinese participants who are healthy as determined by medical evaluation including a detailed medical history, complete physical examination, which includes blood pressure (BP) and pulse rate measurement, clinical laboratory tests, and 12 lead ECG.
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
• Body mass index (BMI) of 19 to 27 kg/m2; and a total body weight >50 kg.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, 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).
• History of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C, or syphilis; positive testing for HIV, hepatitis B, hepatitis C, and serological reaction of syphilis. Infection with hepatitis B or hepatitis C viruses according to protocol specific testing algorithm.
• Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination.
• Any history of chronic infections, any history of recurrent infections, any history of latent infections, or any acute infection within 2 weeks of baseline.
• History of disseminated herpes zoster, or disseminated herpes simplex, or recurrent localized dermatomal herpes zoster.
• Previous administration of an investigational drug within 90 days or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PF-06651600; PF-06651600 200 milligrams(mg) once daily for 10 days	Drug: PF-06651600; oral PF-06651600 tablet 200 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Single dose: maximum observed concentration (Cmax)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: time to reach maximum concentration (Tmax)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: area under the concentration-time curve from time 0 to infinity (AUCinf)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: area under the concentration-time curve from time 0 to the time of last quantifiable concentration (AUClast)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: terminal half life (t1/2)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose:AUC24	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: mean residence time (MRT)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: apparent volume of distribution (Vz/F)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Single dose: apparent oral clearance (CL/F)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Multiple Dose: Cmax	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: Tmax	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: AUCtau (tau = 24 hours)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: t1/2	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: accumulation ratio on AUCtau (Rac)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: accumulation ratio on Cmax(Rac, Cmax)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: lowest concentration observed during the dosing interval (Cmin)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: average concentration at steady state (Cav)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: MRT	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: apparent volume of distribution at steady state (Vss/F)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: CL/F	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: peak trough fluctuation (PTF)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: peak trough swing (PTS)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Multiple Dose: predicted accumulation ratio to estimate linearity (Rss)	0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	From Day1 till Day17
Number of participants with clinically significant change in vital signs from Baseline	From Day1 till Day17
Number of participants with clinically significant abnormalities in 12-lead electrocardiograms (ECGs)	From Day1 till Day17
Number of participants with clinically significant abnormalities in physical examination findings	From Day1 till Day17

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2020
• Primary Completion (ACTUAL): November 19, 2020
• Study Completion (ACTUAL): November 19, 2020

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (ACTUAL): November 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: B7981036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes