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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: TAK-279 30 mg | Experimental | Participants will receive a single dose of TAK-279 30 milligram (mg) oral tablet on Day 1 followed by Day 6 to Day 19 once daily under fasted condition. |
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| Cohort 2: TAK-279 60 mg | Experimental | Participants will receive a dose of TAK-279 60 mg (2*30mg) oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition. |
|
| Cohort 1 and 2: Placebo 30 mg or 60 mg | Placebo Comparator | Participants will receive TAK-279 30 mg or 60 mg (2*30mg) matching placebo oral tablets on Day 1 followed by Day 6 to Day 19 once daily under fasted condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-279 | Drug | TAK-279 oral tablet. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | Day 19: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96 and 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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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Inclusion criteria:
Participant is willing to participate and is capable of giving informed consent.
Healthy, male or female participants of Chinese descent 18 to 45 years of age, inclusive, at the time of informed consent.
Female participants meets the following contraception requirements: A surgically sterile female participant; or a female participant of nonchildbearing potential with laboratory confirmation of postmenopausal status (that is follicle-stimulating hormone levels greater than [>] 40 milli-international units per milliliter [mIU/mL]); or, if sexually active with a non-sterilized male partner, a female participant who agrees to use a highly effective method of contraception from the signing of informed consent throughout the duration of the study and for 10 days after the last dose. Male participants must agree to comply with effective contraceptive requirements.
Body mass index greater than or equal to (>=) 18.0 kilogram per meter square (kg/m^2) and less than or equal to (<=) 28.0 kg/m^2 at the screening visit.
Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms [ECGs], as deemed by the principal investigator (PI) or designee, including the following:
Participant must be willing and able to understand and fully comply with all study procedures and must be available for the duration of the study.
Exclusion criteria:
Site personnel or their family.
History or presence of clinically significant medical or psychiatric condition or disease.
History of any illness or condition that might confound the results of the study or poses an additional risk to the participant by their participation in the study.
History of allergy to study drug or any of its components.
History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Clinical laboratory values at the time of screening or at check-in:
A participant with out-of-range values may have the test repeated once at each time point (screening or check-in) and the participant may be enrolled if the repeated values are within protocol-specified ranges.
Ingestion of Seville orange- or grapefruit-containing foods or beverages within 7 days prior to check-in.
History of alcohol abuse or drug/chemical abuse within 2 years prior to check-in.
Continuous smoker who has used nicotine- or tobacco-containing products within 1 month prior to the first dosing based on participant self-reporting.
Female participants who have a positive pregnancy test result at the screening visit or at check-in, are planning to become pregnant during the study or are lactating.
Positive results for urine drug test at the screening visit or at check-in.
Herpes infections:
Positive results for non-herpetic viral diseases at the screening visit:
Participant has positive results for human immunodeficiency virus.
Positive results for Tuberculosis (TB) at the screening visit:
Positive result for Coronavirus disease 2019 (COVID-19) PCR test at the screening visit.
Prior and concomitant therapy:
Donation of blood or significant blood loss within 56 days prior to study drug administration. Plasma donation within 7 days prior to the first dosing.
Participation in another clinical study and having received its study drug within 30 days or 5 elimination half-lives prior to study drug administration. The 30-day or 5 elimination half-lives window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | 201100 | China |
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| Label | URL |
|---|---|
| To obtain more information about this study, click this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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| Placebo |
| Drug |
TAK-279 30 mg or 60 mg (2*30mg) matching placebo tablet. |
|
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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 |