Huashan Hospital Fudan University
Shanghai, 201100, China
NCT Number: NCT06111547
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.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 1
Shanghai, 201100, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TAK-279 oral tablet.
TAK-279 30 mg or 60 mg (2*30mg) matching placebo tablet.
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
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
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
Cmax 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
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
Cmax,ss of TAK-279 in plasma will be assessed.
Time frame: From start of study drug administration up to follow-up (up to Day 36)
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 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: Day 1: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours post-dose
AUC0-24 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
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
t1/2 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
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
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
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
Cmin of TAK-279 will be assessed.
Time frame: Pre-dose on Day 17, Day 18 and Day 19
Ctrough 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
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
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
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
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 will be assessed, calculated as 100%*([Cmax,ss-Ctrough]/Cavg) 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 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 calculated from AUCtau at steady state and AUC0-24 indicated a single dose will be assessed.
Takeda
Industry
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Oral Doses Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of TAK-279 in Healthy Chinese Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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