Healthy Participants
Conditions
Brief 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.
Interventions
DRUGPF-06651600
oral PF-06651600 tablet 200 mg once daily
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| 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 |
Countries
China
Outcome results
None listed