HEALTHY
Conditions
Brief summary
The purpose of this study is to assess the pharmacokinetics, safety and tolerability of PF-04965842 after single dose and once-daily multiple-doses in Chinese healthy participants.
Detailed description
This is a Phase 1, open-label, single-arm, single- and multiple-dose study to assess the pharmacokinetics, safety and tolerability of PF-04965842 in Chinese healthy participants.
Interventions
DRUGPF-04965842
For this study, the investigational product is PF-04965842 (provided as 100 mg tablet). PF-04965842 100 mg tablets will be provided by Pfizer. Investigational product will be presented to the participants in individual dosing containers
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open-label, single-arm, single- and multiple-dose study
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) of 19 to 26 kg/m2; and a total body weight \>50 kg. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Exclusion criteria
* Evidence or clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic (including alcoholic liver disease, nonalcoholic steatohepatitis (NASH), autoimmune hepatitis, and hereditary liver diseases), 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, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and serological reaction of syphilis. As an exception, a positive hepatitis B surface antibody (HBsAb) finding as a result of participant vaccination is permissible. * Evidence or history of clinically significant dermatological condition (eg, contact dermatitis or psoriasis) or visible rash present during physical examination. * History of tuberculosis (TB) or active or latent or inadequately treated infection, positive QuantiFERON- TB Gold test or positive chest radiographs for active tuberculosis infection. * 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. * Have any malignancies or have a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ. * A positive urine drug test. * Screening sitting blood pressure (BP) \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is \>=140 mm Hg (systolic) or \>=90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. * Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level \>=1.5 × upper limit of normal (ULN); Total bilirubin level \>1 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<=1 × ULN.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration time profile from time zero to time tau | The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1 and Day8 | PK parameters derived from plasma PF-04965842 concentration |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1 | PK parameters derived from plasma PF-04965842 concentration |
| Maximum Observed Plasma Concentration (Cmax) | The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1 | PK parameters derived from plasma PF-04965842 concentration |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | The pharmacokinetic samples will be collected at 0 (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours after dosing on Day 1 | PK parameters derived from plasma PF-04965842 concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Screening up to follow up (71 days) | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Tests | Screening up to follow up (71 days) | Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. |
| Number of Pariticipants With Clinically Significant Change From Baseline in Vital Signs | Screening up to follow up (71 days) | Sitting BP will be measured with the participant's arm supported at the level of the heart, with feet flat on the floor and back supported, and recorded to the nearest mm Hg after approximately 5 minutes of rest. |
| Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings | Screening up to follow up (71 days) | All scheduled ECGs should be performed after the participant has rested quietly for at least 10 minutes in a supine position. |
Countries
China
Outcome results
None listed