Healthy
Conditions
Keywords
safety, istaroxime
Brief summary
Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.
Detailed description
32 subjects (F: M=1:1) were randomized in three dose groups (0.25-0.5-1.0ug/kg/min). 8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS; 12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects). All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic. At least 1 week should be kept between two dose groups. Escalation to the higher dose will occur after the lower dose group has been completed and no significant safety issues are found.
Interventions
DRUGistaroxime
8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS fo12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).
DRUG9% Saline (NS)
infusion for 24 hours
Sponsors
CVie Therapeutics Co. Ltd.
Lee's Pharmaceutical Limited
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. Age at 18-45 years (inclusive) 2. Male or Non-pregnant, non-lactating women 3. Chinese healthy subjects 4. Body mass index (BMI) at 19-24 kg/m2 (inclusive) and body weight at 50-100kg 5. Lab examinations (include but not limited: Hemoglobin, white blood cell counting, differential count, creatinine,Alkaline phosphatase (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT),Total bilirubin and urinalysis) are within normal range or out of normal range but no clinical significance. 6. Vital signs in screening phase: SBP100-139mmHg, DBP 50-89 mmHg, pulse rate 45-90 bpm. Holter is within normal range or out of normal range but no clinical significance. 7. Both physical examination and ECG at baseline are normal or abnormal but no clinical significance 8. Women of childbearing age during the trial must be willing to use a medically acceptable method of contraception, which include surgical sterilization (tubal ligation / hysterectomy), and double barrier methods of hormonal contraception. 9. Subjects well communicate with investigators, understanding the requirements of investigators and being willing to sign the ICF before conducting any study-related procedure. 10. Subjects are willing to stay at the phase I ward throughout the study.
Exclusion criteria
1. Disease history in liver, kidney, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal tract, lungs, immune, skin, blood, or metabolic disorders or cancer, that may have great impact on the study results. 2. Presence of pancreatitis, intestinal obstruction, glaucoma, prostatic hypertrophy, adrenal disease, hyperthyroidism or gallbladder disease (subjects had experienced cholecystectomy will not be excluded) 3. History of clinical significant disease in the past 4 weeks before screening visit 4. Presence of diseases which are known to disturb the absorption, distribution, metabolism or excretion of Istaroxime 5. Physical examinations, medical history, ECG, vital signs or lab examination are deemed to be abnormal and clinical significant 6. Be intolerant or allergy to Istaroxime, lactose or any similar substances 7. Significantly abnormal diets are conducted within 4 weeks before screening visit 8. Blood donation or loss equal to or exceeds 400ml in the past 6 months 9. Participating in the any other drug study in the past 3 months 10. Administrated OTC drugs including vitamin supplements and herbal (Occasional use of paracetamol will not be excluded) 11. Regular use of any prescription drug (Hormonal birth control pills or hormone replacement therapy will not be excluded) 12. Drinking beverage or eat food containing caffeinated / xanthine or poppy seed since 48 hours before study drugs administration; or drinking beverage or eat food containing grapefruit, oranges or Chinese tea 14 days before the study drug administration 13. Receiving the therapy of drugs including cytochrome P450 3A4 or cytochrome P450 2C8 inhibitors or inducers (eg barbiturates, carbamazepine, erythromycin, phenytoin, thiazoline TZDs, Rifampin) 14. Women at Lactation period or with positive pregnancy test 15. Tongue piercing or lip piercing occurred 30 days before the study drug administration 16. Smoke or tobacco is used 60 days before the study drug administration 17. History of abusing any substance including infusion drugs, alcohol and opium 18. Positive alcohol breathing test within 1day or drink alcohol within 1week 19. Abusing drugs (include Opioids, oxycodone, methamphetamine, amphetamine, cannabinoids, cocaine, barbiturates, benzodiazepines class, methadone, buprenorphine and phencyclidine) 20. History of heart disease 21. Planning to be pregnant in the recent 3 months 22. Participating any other interventional strudy in the past 30 days 23. History of bronchial asthma or blood porphyria disease 24. HbsAg, anti-HCV, anti-HIV or anti - syphilis are positive 25. Holter examination is abnormal and clinical significant 26. Subjects are not eligible for the study judged by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety of istaroxime in healthy volunteers is measured by varition of heart functon, blood pressure and heart ratio | one week | safety of istaroxime in healthy volunteers is measured by |
Countries
China
Outcome results
None listed