Health Adult Subjects
Conditions
Brief summary
To evaluate the safety, the tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of ENERGI-F705 Tablets in healthy subjects.
Interventions
DRUGENERGI-F705 Tablets 60 mg
ENERGI-F705 tablets administered orally under fasting conditions.
DRUGENERGI-F705 Tablets 120 mg
ENERGI-F705 tablets administered orally under fasting conditions.
DRUGVehicle Control
Matched vehicle control tablets administered orally under fasting conditions.
Sponsors
Energenesis Biomedical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. All genders aged ≧18 to \< 45 years. 2. Able to understand and sign informed consent form. 3. Able to communicate well with the Investigator and comply with the requirements of the study. 4. Body mass index (BMI) ranged 18.5≦BMI \< 27 kg/m2 . 5. Males weighting ≧50 kg and females weighting ≧45 kg. 6. Healthy subjects as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, chest X-ray, and clinical laboratory evaluations. 7. Is willing to follow the study life style instruction and protocol procedure 8. Negative test for human immunodeficiency virus (HIV), syphilis, hepatitis B virus surface antigen (HBsAg), and anti-HCV antibody at screening. \-
Exclusion criteria
1. History of adverse reactions or allergy of active ingredient, components in IP or related products. 2. Significant drug abuse. 3. Having any medical history as judged by the Investigator (including but not limited to neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorders). 4. Presence of significant neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, renal, or other pathology, as judged by the Investigator. 5. Pregnant or lactating women. 6. Having an acute illness or surgery within 4 weeks prior to dosing. 7. Other conditions not suitable for participating in this study as judged by the Investigator. 8. History of cancer (malignancy) or have ever received any anti-cancer therapy. 9. Taking any prescription, vaccine, herbal products or over-the-counter (OTC) medication, including antacids, calcium, other supplements and vitamins, that may interfere with the safety or PK/PD assessment judged by the Investigator within 14 days prior to dosing. 10. Joining any drug clinical trial within 2 months prior to dosing. 11. Blood loss/donation of ≧250 mL within 2 months or blood loss/donation of ≧500 mL within 3 months prior to dosing. 12. Healthy adult subjects or subjects' active sexual partners disagree to use at least one form of highly effective contraceptive methods during the study period and for 5 half-lives of active ingredient plus 90 days (94 days in total) after dosing. During this time, sperm or egg donation is prohibited while contraceptive methods are in use. * Acceptable forms of highly effective contraceptive methods for female subjects include: * Surgically sterile (documented hysterectomy, documented bilateral salpingectomy, bilateral oophorectomy) * Placement of an intrauterine device (IUD) in conjunction with a barrier method (use of condom by the male partner) * Total sexual abstinence * Acceptable forms of highly effective contraceptive methods for male subjects include: * Surgically sterile (vasectomy with documented negative semen analysis) * Condom in conjunction with an IUD (used by the female partner) * Condom in conjunction with oral/implantable/injectable contraceptives (used by the female partner) * Total sexual abstinence 13. Having a rare hereditary problem of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. 14. The result of AST or ALT \>2 times the upper limit of normal or presence of clinically significant abnormality, as judged by the Investigator. 15. The result of creatinine is abnormal or eGFR \< 90 mL/min/1.73 m2 or presence of clinically significant abnormality, as judged by the Investigator. 16. Presence of, history of, or suspected gout, hyperuricemia or urolithiasis, as judged by the Investigator. 17. Clinically significant ECG abnormality at screening. 18. Presence of risk for QT prolongation, as judged by the Investigator. 19. Regular smoker. * Regular smoker is defined as who smokes every day (≥ 1 cigarette/day in average in the past 8 weeks of Screening) 20. Consumed greater than 3 units of alcoholic beverages per day in average for the past 4 weeks prior to dosing. * One unit is equivalent to one can of beer (\<10% alcohol; about 330 mL), one glass of wine (10\~20% alcohol; about 150 mL), or one shot of distilled spirits (\>20% alcohol; about 45 mL)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and Percentage of Subjects with Treatment-Emergent Adverse Events (TEAEs) | From dosing through end of study (approximately 4 days post-dose) | Number and percentage of subjects with treatment-emergent adverse events (TEAEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Whole Blood Concentration (Cmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration | From pre-dose to 72 hours post-dose | Cmax is defined as the highest observed whole blood concentration within the 72-hour sampling period. Values will be reported separately for ENERGI-F705 and its metabolite in ng/mL. |
| Time to Maximum Observed Whole Blood Concentration (Tmax) of ENERGI-F705 and Its Metabolite Following Single Oral Administration | From pre-dose to 72 hours post-dose | Tmax is defined as the time point at which Cmax is observed within the 72-hour sampling period. Values will be reported separately for ENERGI-F705 and its metabolite in hours. |
| Trough Whole Blood Concentration (Ctrough) of ENERGI-F705 and Its Metabolite at 72 Hours Following Single Oral Administration | From pre-dose to 72 hours post-dose | Ctrough is defined as the whole blood concentration measured at 72 hours post-dose. Values will be reported separately for ENERGI-F705 and its metabolite in ng/mL. |
| Area Under the Whole Blood Concentration-Time Curve (AUC) of ENERGI-F705 and Its Metabolite Following Single Oral Administration | From pre-dose to 72 hours post-dose | AUC0-t is defined as the area under the concentration-time curve from time zero to the last measurable concentration time point. AUC0-∞ is defined as the area under the concentration-time curve from time zero to infinity. Both values will be reported separately for ENERGI-F705 and its metabolite in ng·h/mL. |
| Terminal Elimination Half-life (T½) of ENERGI-F705 and Its Metabolite Following Single Oral Administration | From pre-dose to 72 hours post-dose | T½ is defined as the terminal half-life, calculated as ln(2) / K\_el ≈ 0.693 / K\_el. Values will be reported separately for ENERGI-F705 and its metabolite in hours. |
| Apparent Total Body Clearance (CL/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration | From pre-dose to 72 hours post-dose | CL/F is defined as the apparent total body clearance, calculated as Dose / AUC0-∞. Values will be reported separately for ENERGI-F705 and its metabolite in L/h. |
| Apparent Volume of Distribution (Vd/F) of ENERGI-F705 and Its Metabolite Following Single Oral Administration | From pre-dose to 72 hours post-dose | Vd/F is defined as the apparent volume of distribution, calculated as Dose / (K\_el × AUC0-∞). Values will be reported separately for ENERGI-F705 and its metabolite in liters (L). |
| Whole Blood Adenosine Triphosphate (ATP) Level Following Single Oral Administration of ENERGI-F705 Tablets | From pre-dose to 72 hours post-dose | ATP levels will be measured in whole blood at each scheduled time point within the 72-hour sampling period. |
Countries
Taiwan
Outcome results
None listed