- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02477449
Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers
June 19, 2015 updated by: Lee's Pharmaceutical Limited
A Phase I Dose Escalating Study Evaluating the Pharmacokinetics, Tolerability and Safety of Istaroxime Infusion for 24 Hours in Chinese Healthy Volunteers
Phase 1 study to investigate safety of istaroxime in healthy chinese volunteers.
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China, 100071
- Recruiting
- The 307th Hospital of Chinese People's Liberation Army
-
Contact:
- Ruihua Dong, MD
- Phone Number: +86-10-66947798
-
Contact:
- Hengyan Qu, MD
- Phone Number: +86-10-66947798
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Smoke or tobacco is used 60 days before the study drug administration
- History of abusing any substance including infusion drugs, alcohol and opium
- Positive alcohol breathing test within 1day or drink alcohol within 1week
- Abusing drugs (include Opioids, oxycodone, methamphetamine, amphetamine, cannabinoids, cocaine, barbiturates, benzodiazepines class, methadone, buprenorphine and phencyclidine)
- History of heart disease
- Planning to be pregnant in the recent 3 months
- Participating any other interventional strudy in the past 30 days
- History of bronchial asthma or blood porphyria disease
- HbsAg, anti-HCV, anti-HIV or anti - syphilis are positive
- Holter examination is abnormal and clinical significant
- Subjects are not eligible for the study judged by investigators
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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).
|
Experimental: 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.
|
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).
infusion for 24 hours
|
Experimental: 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.
|
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).
infusion for 24 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
safety of istaroxime in healthy volunteers is measured by varition of heart functon, blood pressure and heart ratio
Time Frame: one week
|
safety of istaroxime in healthy volunteers is measured by
|
one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
July 1, 2015
Study Completion (Anticipated)
August 1, 2015
Study Registration Dates
First Submitted
June 17, 2015
First Submitted That Met QC Criteria
June 19, 2015
First Posted (Estimate)
June 22, 2015
Study Record Updates
Last Update Posted (Estimate)
June 22, 2015
Last Update Submitted That Met QC Criteria
June 19, 2015
Last Verified
June 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CVie2015001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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