PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634565
• Other study ID #: B7981036
• Status: Completed
• Phase: Phase 1
• Start date: October 15, 2020
• Est. completion date: November 19, 2020

Study information

• Verified date: February 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 19, 2020
• Est. primary completion date: November 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• PF-06651600
oral PF-06651600 tablet 200 mg once daily

Locations

Country	Name	City	State
China	North District of Peking University Third Hospital	Beijing
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Single dose:AUC24		0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day1
Primary	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
Primary	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
Primary	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
Primary	Multiple Dose: Cmax		0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Primary	Multiple Dose: Tmax		0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Multiple Dose: MRT		0, 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 12, 16 and 24 hours after dosing on Day10
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)		From Day1 till Day17
Primary	Number of participants with clinically significant change in vital signs from Baseline		From Day1 till Day17
Primary	Number of participants with clinically significant abnormalities in 12-lead electrocardiograms (ECGs)		From Day1 till Day17
Primary	Number of participants with clinically significant abnormalities in physical examination findings		From Day1 till Day17

External Links

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