Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers

NCT ID: NCT02477449

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-10-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

low dose group

8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS; All the subjects were given infusion of study drugs for 24 hours, and then were observed for 48 hours in the clinic.

Group Type: EXPERIMENTAL

istaroxime

Intervention Type: DRUG

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).

mid dose group

12 subjects in 0.5ug/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.

Group Type: EXPERIMENTAL

istaroxime

Intervention Type: DRUG

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).

9% Saline (NS)

Intervention Type: DRUG

infusion for 24 hours

high dose group

12 subjects in 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.

Group Type: EXPERIMENTAL

istaroxime

Intervention Type: DRUG

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).

9% Saline (NS)

Intervention Type: DRUG

infusion for 24 hours

Interventions

istaroxime

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).

Intervention Type: DRUG

9% Saline (NS)

infusion for 24 hours

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CVie Therapeutics Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Lee's Pharmaceutical Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The 307th hospital of chinese People's liberation army

Beijing, , China

Countries

China

Other Identifiers

CVie2015001

Identifier Type: -

Identifier Source: org_study_id