The purpose of this study is to compare the pharmacokinetics (PK) and safety of AG-881 in healthy Japanese and Non-Asian participants after single oral doses of 10 mg and 50 mg of AG-881.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
32
AG-881 tablets.
WCCT GLobal
Cypress, California, United States
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Time of the Last Measurable Concentration (AUC0-last) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-∞) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Clearance Following Extravascular Dosing (CL/F) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Maximum Plasma Concentration Observed (Cmax) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Terminal Elimination Half-life (t1/2) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Time of Maximum Plasma Concentration (tmax) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Apparent Volume of Distribution (Vd/F) of AG881
Time frame: Pre-dose and multiple time points post-dose (up to 504 hours) after each administration of AG-881
Number of Participants with Changes in Clinical Laboratory Tests from Screening to 22 days in Period 1 and 2
Clinical laboratory assessments will include hematology, blood chemistry, and urinalysis.
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Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Physical Examinations from Screening to 22 days in Period 1 and 2
Physical examination will include, examination of skin, neurological, respiratory, cardiovascular, and gastrointestinal systems.
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Vital Sign Measurements from Screening to 22 days in Period 1 and 2
Vital sign measurements will include body temperature, respiratory rate, blood pressure, and heart rate.
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Changes in Electrocardiograms (ECGs) from Screening to 22 days in Period 1 and 2
Time frame: Screening (Day -1) up to 22 days in Period 1 and 2 (Each Period is 22 days)
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence associated with the use of a drug, whether or not considered drug-related.
Time frame: Up to 28 days after last dose of AG-881 (Up to 71 days)
Number of Participants Using Concomitant Medications
Time frame: Up to 28 days after last dose of AG-881 (Up to 71 days)