None
Conditions
Interventions
Cohort 1 (TAK-279 Group):TAK-279 30 mg, once daily (QD), oral
Cohort 1 (Placebo Group):Placebo, once daily (QD), oral
Cohort 2 (TAK-279 Group):TAK-279 60 mg, once daily (QD), oral
Cohort 2 (Placebo Group):Placebo, once daily (QD), oral
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. The subject is willing to participate in the study and is able to provide informed consent. 2. Healthy Chinese male or female subjects, aged 18 to 45 years (inclusive) at the time of signing the informed consent form. 3. Female subjects shall meet the following contraception requirements: female subjects who are surgically sterile; or female subjects confirmed by laboratory tests to be postmenopausal (i.e., follicle-stimulating hormone level >40 mIU/mL) and infertile; or, if engaging in sexual activity with a non-sterile male partner, the female subject agrees to use highly effective contraception methods from signing the informed consent form throughout the study period and within 10 days after the last dose. Male subjects must agree to comply with effective contraception requirements. 4. Body mass index (BMI) at screening visit >=18.0 kg/m^2 and =90/50 mmHg and =50 beats per minute (bpm) and <=100 bpm. (3) ECG results assessed by the PI or designated personnel at screening visit are normal, or abnormal but not clinically significant. 6. The subject must be willing and able to understand and fully comply with all study procedures, and must have time to participate in the study during the study period.
Exclusion criteria
Exclusion criteria: 1. Site personnel or their family. 2. Is mentally or legally incapacitated at the time of the screening visit or expected to become so during the conduct of the study. 3. History or presence of clinically significant medical or psychiatric condition or disease. 4. History of any illness or condition that might confound the results of the study or poses an additional risk to the subject by their participation in the study. 5. History of any illness or condition that might confound the results of the study or poses an additional risk to the subject by their participation in the study. 6. 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). 7. Clinical laboratory values at the time of screening or at check-in: (1) AST or ALT >1.5× the ULN. (2) CPK > the ULN. (3) Hemoglobin <11.0 g/dL (<110.0 g/L). (4) Absolute neutrophil count <1.8 × 10^9/L (<1800/mm^3). (5) Absolute lymphocyte count <0.8 × 10^9/L (<800/mm^3). (6) Platelet count <100 × 10^9/L (<100,000/mm^3). A subject with out-of-range values may have the test repeated once at each time point (screening or check-in) and the subject may be enrolled if the repeated values are within protocol-specified ranges. 8. Ingestion of Seville orange- or grapefruit-containing foods or beverages within 7 days prior to check-in. 9. History of alcohol abuse or drug/chemical abuse within 2 years prior to check-in. 10. Continuous smoker who has used nicotine- or tobacco-containing products within 1 month prior to the first dosing based on subject self-reporting. 11. Female subjects 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. 12. Female subjects 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. 13. Herpes infections: (1) Subject has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at screening or check-in. (2) Subject has a history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes simplex virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years); 14. Positive results for nonherpetic viral diseases at the screening visit: (1) Subject has presence of hepatitis C virus (HCV) antibody OR a positive confirmatory test result for HCV RNA (nucleic acid test or polymerase chain reaction [PCR]). (2) Subject has presence of positive result for hepatitis B surface antigen, presence of hepatitis B virus deoxyribonucleic acid, or positive anti-hepatitis B core antibody without concurrent positive hepatitis B surface antibody. (3) Subject has positive results for human immunodeficiency virus. 15. Positive results for tuberculosis (TB) at the screening visit: (1) The subject has a history of active TB infection, regardless of treatment status. (2) The subject has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator. (3) The subject has evidence of latent TB as evidenced by a positive QuantiFERON-TB Gold (QFT) result or T-Spot OR 2 indeterminant QFT results or 2 borderlin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of TAK-279 in plasma after single-dose administration: AUC0-t, AUC0-inf, and Cmax;Pharmacokinetic parameters of TAK-279 in plasma after multiple-dose administration: AUCtau and Cmax,ss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional pharmacokinetic parameters of TAK-279 in plasma: AUC0-24, ?z, t1/2, CL/F, Vz/F, Tmax, Cmin after single-dose administration on Day 1; Ctrough, Tmax,ss, CLss/F, Vss/F, Cavg, ?z, t1/2, %FLUC, and accumulation ratio of Cmax and AUCtau after multiple-dose administration on Day 19; | — |
Countries
China
Contacts
Public ContactZhang Jing
Huashan Hospital, Fudan University
Outcome results
None listed