The main aim of this study is to find out how the body of a healthy Chinese adult processes TAK-279 (pharmacokinetics). Other aims are to learn about side effects and how well TAK-279 is tolerated when given to healthy Chinese Adults. Participants will receive either TAK-279 or a placebo on Day 1 and from Day 6 to Day 19. Blood samples will be taken at different timepoints throughout the study participation. Participants will need to adhere to certain lifestyle restrictions during the study. This also includes eating and drinking restrictions. During the study, participants will need to stay at the clinic for 25 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
24
Huashan Hospital Fudan University
Shanghai, China
Area Under the Concentration Time Curve From Time 0 to the Time t (AUC0-t) of TAK-279
AUC0-t of TAK-279 in plasma will be assessed.
Time frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Area Under the Concentration-time Curve From Time 0 To Infinity (AUC0-inf) of TAK-279
AUC0-inf of TAK-279 in plasma will be assessed.
Time frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of TAK-279
Cmax of TAK-279 in plasma will be assessed.
Time frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Area Under the Concentration-Time Curve During a Dosing Interval (AUCtau) of TAK-279
AUCtau of TAK-279 in plasma will be assessed.
Time frame: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of TAK-279
Cmax,ss of TAK-279 in plasma will be assessed.
Time frame: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Adverse Events of Special Interest (AESI)
Number of participants with TEAEs, serious TEAEs and AESI will be reported.
Time frame: From start of study drug administration up to follow-up (up to Day 36)
Number of Participants With Clinically Significant Changes in 12-Lead Electrocardiogram (ECG), Vital Signs and Clinical Laboratory Parameters
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Number of participants with clinically significant changes in ECG, vital signs, and clinical laboratory parameters will be assessed. Clinical significance of ECG, vital signs, and clinical laboratory parameters will be determined at the investigator's discretion.
Time frame: From start of study drug administration up to follow-up (up to Day 36)
Area Under the Plasma Concentration-Time Curve From Time 0 To the Time 24 Hours (AUC0-24) of TAK-279
AUC0-24 of TAK-279 in plasma will be assessed.
Time frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
Terminal Elimination Rate Constant (Lambda z) of TAK-279 at Day 1 and Day 19
Lambda z of TAK-279 in plasma will be assessed.
Time frame: Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Terminal phase half-life (t1/2) of TAK-279 at Day 1 and Day 19
t1/2 of TAK-279 in plasma will be assessed.
Time frame: Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Apparent Clearance (CL/F) of TAK-279
CL/F of TAK-279 in plasma will be assessed.
Time frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of TAK-279
Vz/F of TAK-279 in plasma will be assessed.
Time frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Time to Reach Peak Plasma Concentration (Tmax) of TAK-279
Tmax of TAK-279 in plasma will be assessed.
Time frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Minimum Plasma Concentration (Cmin) of TAK-279
Cmin of TAK-279 will be assessed.
Time frame: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Trough Concentration (Ctrough) of TAK-279
Ctrough of TAK-279 will be assessed.
Time frame: Pre-dose on Day 17, Day 18 and Day 19
Time to Reach the Maximum Plasma Concentration at Steady State (Tmax,ss) of TAK-279
Tmax,ss of TAK-279 will be assessed.
Time frame: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Total Body Drug Clearance at Steady State (CLss/F) of TAK-279
CLss/F of TAK-279 will be assessed.
Time frame: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Apparent Volume of Distribution at Steady State (Vss/F) of TAK-279
Vss/F of TAK-279 will be assessed.
Time frame: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Average Plasma Concentration (Cavg) for TAK-279
Cavg of TAK-279 will be assessed, calculated as AUC(tau)/tau. Tau is defined as length of dosing interval.
Time frame: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Percent peak-to-trough fluctuation (%FLUC) of TAK-279
Percent peak-to-trough fluctuation will be assessed, calculated as 100%\*(\[Cmax,ss-Ctrough\]/Cavg) will be assessed.
Time frame: Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Accumulation Ratio for Cmax (RA, Cmax) of TAK-279
Accumulation ratio calculated from Cmax,ss at steady state and Cmax indicated a single dose will be assessed.
Time frame: Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose
Accumulation Ratio for AUCtau (RA, AUCtau) of TAK-279
Accumulation ratio calculated from AUCtau at steady state and AUC0-24 indicated a single dose will be assessed.
Time frame: Day 1 and Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose