None listed
Conditions
Interventions
Drug : G1: AST-001 10g PO single dose
G2: ASR-001 20g PO single dose
G3: AST-001 30g PO single dose and 7-day washout period, after AST-001 15g QD, AST-001 15g BID for 7 days
Sponsors
Astrogen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Helthy male between the ages of 19 and 55 years at the time of screening 2. 50~90 kg of body weight and 18.0~29.0 kg/m2 of BMI 3. Judged to be eligible for enrollment by the physician according to physical examination, history laboratory tests 4. Judged to be eligible for enrollment by laboratory test result according to protocol 5. Decided to participate in the clinical trial voluntarily, and provided written consent to follow the clinical trial guidelines
Exclusion criteria
Exclusion criteria: 1. Has a current or past history of a clinically significant disorder in the cardiovascular, respiratory, liver, kidney, neurological, endocrinal, hemato-oncological, psychological, urological systems 2. Has a current or past history of gastrointestinal disease or has a history of surgery that can influence in evaluating the safety and pharmacokinetic of the study drug 3. Has a history of hypersensitivity to AST-001, drugs containing a similar substance, or other drugs or a history of clinically significant hypersensitive reaction 4. Has genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose absorption disorder 5. Has a current or past history of a clinically significant muscle disease 6. At screening, systolic BP <100mmHg or >150mmHg, diastolic BP <70mmHg or >100mmHg 7. At screening laboratory tests, - AST, ALT, r-GT > values more than 2 times the upper limits of normal - Total bilirubin > 2.0 mg/dL - CK > values more tnan 2.5 times the upper limits of normal - eGFR < 60 mL/min/1.73 m2 8. Heavy drinker(more than 21 units/week of alcohol) or cannot stop alcohol drinking for the study period 9. Heavy smoker(>10 cigarttes/day) or cannot stop smoking for the admisson period 10. Has donated whole blood within 60 days of study drug administration, apheresis within 30 days of study drug administration or has received transfusion within 30 days of study drug administration 11. Has taken any prescription medicine, herbal medicine within 14 days of study drug administration, or any over-the-counter drugs, nutritional agents including amino acids within 7 days of study drug administration 12. Has taken drugs that may induce or suppress drug metabolic enzymes, such as barbiturates within 30 days of study drug administration 13. Has a history of drug abuse or has positive urine screening results for drug abuse 14. Has ingested food products that may affect drug absorption, distribution, metabolism or excretion within 7 days of study drug administration 15. Has taken other clinical trial drugs within 6 months of the study drug administration 16. Has a clinically significant abnormal results in screening laboratory tests 17. Judged to be ineligible by the study investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUCt, AUCinf, tmax, AUCt/inf, tmax, AUCt/inf, t1/2, CL/F, Vz/F, Cmaxss, AUCtauss etc;Cmax, AUCt, AUCinf, tmax, AUCt/inf, tmax, AUCt/inf, t1/2, CL/F, Vz/F, Cmaxss, AUCtauss etc;Cmax, AUCt, AUCinf, tmax, AUCt/inf, tmax, AUCt/inf, t1/2, CL/F, Vz/F, Cmaxss, AUCtauss etc;Cmax, AUCt, AUCinf, tmax, AUCt/inf, tmax, AUCt/inf, t1/2, CL/F, Vz/F, Cmaxss, AUCtauss etc | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability outcome 1: Physical examination;Safety and tolerability outcome 2: Vital sign;Safety and tolerability outcome 3: ECG;Safety and tolerability outcome 4: Laboratory test,;Safety and tolerability outcome 5: Adverse event, Concomittant medication | — |
Countries
Korea, Republic of
Contacts
Public ContactSoyoung Lee
Seoul National University Hospital
Outcome results
None listed