Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers

NCT02477449 | Completed Phase 1

• 1 other identifier: CVie2015001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.

Conditions

Healthy

Keywords

safety; istaroxime

Outcome Measures

Primary Outcomes (1)

• safety of istaroxime in healthy volunteers is measured by varition of heart functon, blood pressure and heart ratio

  safety of istaroxime in healthy volunteers is measured by

  one week

Study Arms (3)

low dose group

EXPERIMENTAL

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.

Drug: istaroxime

mid dose group

EXPERIMENTAL

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.

Drug: istaroxime; Drug: 9% Saline (NS)

high dose group

EXPERIMENTAL

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.

Drug: istaroxime; Drug: 9% Saline (NS)

Interventions

istaroxime 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).

high dose group; low dose group; mid dose group

9% Saline (NS) DRUG

infusion for 24 hours

high dose group; mid dose group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age at 18-45 years (inclusive)
• Male or Non-pregnant, non-lactating women
• Chinese healthy subjects
• Body mass index (BMI) at 19-24 kg/m2 (inclusive) and body weight at 50-100kg
• 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.
• 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.
• Both physical examination and ECG at baseline are normal or abnormal but no clinical significance
• 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.
• Subjects well communicate with investigators, understanding the requirements of investigators and being willing to sign the ICF before conducting any study-related procedure.
• Subjects are willing to stay at the phase I ward throughout the study.

You may not qualify if:

• 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.
• Presence of pancreatitis, intestinal obstruction, glaucoma, prostatic hypertrophy, adrenal disease, hyperthyroidism or gallbladder disease (subjects had experienced cholecystectomy will not be excluded)
• History of clinical significant disease in the past 4 weeks before screening visit
• Presence of diseases which are known to disturb the absorption, distribution, metabolism or excretion of Istaroxime
• Physical examinations, medical history, ECG, vital signs or lab examination are deemed to be abnormal and clinical significant
• Be intolerant or allergy to Istaroxime, lactose or any similar substances
• Significantly abnormal diets are conducted within 4 weeks before screening visit
• Blood donation or loss equal to or exceeds 400ml in the past 6 months
• Participating in the any other drug study in the past 3 months
• Administrated OTC drugs including vitamin supplements and herbal (Occasional use of paracetamol will not be excluded)
• Regular use of any prescription drug (Hormonal birth control pills or hormone replacement therapy will not be excluded)
• 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
• Receiving the therapy of drugs including cytochrome P450 3A4 or cytochrome P450 2C8 inhibitors or inducers (eg barbiturates, carbamazepine, erythromycin, phenytoin, thiazoline TZDs, Rifampin)
• Women at Lactation period or with positive pregnancy test
• Tongue piercing or lip piercing occurred 30 days before the study drug administration

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead
• CVie Therapeutics Co. Ltd.: collaborator

Study Sites (1)

The 307th hospital of chinese People's liberation army

Beijing, 100071, China

Location

MeSH Terms

Interventions

Istaroxime; Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2015
• First Posted: June 22, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)