- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495206
Safety, Tolerability and Pharmacokinetics of Y-2(Edaravone And Borneol) Sublingual Tablet
February 13, 2020 updated by: Yantai YenePharma Co., Ltd.
Sublingual Y-2(Edaravone And Borneol) Tablet For Acute Ischemic And Hemorrhagic Patients-the SALVAGE Trial
The primary objective is to evaluate the safety and tolerability of single ascending dose of Y-2 sublingual tablets in healthy male and female adult subjects.
The secondary objective is to characterize the single-dose pharmacokinetics of Y-2 sublingual tablets in healthy male and female adult subjects.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This study will be a single-center, single ascending dose study in healthy male and female subjects.
A total of 24 subjects, 4 cohorts of 6 subjects each, will be enrolled in this study.
All of the 6 subjects in each cohort will receive a single dose of Y-2 sublingual tablet on a single occasion.
Prior to taking the drug and after taking the drug at 5 min to 24 h, venous blood from all subjects will be collected at different time points for PK analysis.
After dosing, safety and tolerability data for each cohort will be evaluated.
Study Type
Interventional
Enrollment (Anticipated)
24
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 Contact
- Name: David Z. Wang, M.D.
- Phone Number: (309) 624-9500
- Email: david.wang@chinastroke.net
Study Locations
-
-
Illinois
-
Peoria, Illinois, United States, 61637
- Recruiting
- OSF Healthcare System d/b/a Saint Francis Medical
-
Contact:
- David Z Wang, M.D
-
Principal Investigator:
- David Z Wang, M.D
-
-
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 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adult male and female subjects, 18-55 years of age, Body weight ≥ 50 kg and body mass index (BMI) within the range of 18 - 30 kg/m2;
- Women of childbearing potential with a negative urine pregnancy test at screening and check-in, who are not breastfeeding, do not plan to become pregnant during the study, and agree to use an approved alternative method of family planning during the study;
- Male subjects must agree to use barrier contraception (condom with spermicide) in addition to having their female partner (if of child-bearing potential) use another acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) from first dose until 30 days following the last administration of study drug;
- Female subjects, if of child-bearing potential, must agree to use an acceptable form of contraception (IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, or subdermal hormonal implant) in addition to having their male partner use barrier contraception (condom with spermicide) from first dose until 30 days following the last administration of study drug. Female subjects who are NOT of child-bearing potential include those who have a history of tubal ligation, hysterectomy, or bilateral salpingo oopherectomy, or who have had no menstrual period for >12 months, confirmed by a screening follicle stimulating hormone (FSH) level in the post-menopausal range;
- Hemoglobin level within normal limits (WNL) of the reference laboratory value (one repeat is allowed for a hemoglobin level that falls within 0.3 g/dL of the upper or lower limit of the reference range);
- Subjects who are able to understand and give their signed informed consent before any trial related procedures are performed.
- Exclusion Criteria:
- Subjects have a history of, cancer (not including basal cell skin cancer greater than 5 years prior), diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, hematological, dermatological, neurological, psychiatric or other major disorder;
Presence or history of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of medicines;
- Urine protein > trace on a standard dip stick test (1 repeat allowed); Microscopic hematuria defined as >5 red blood cells (RBC) per high powered field (HPF) in a male or a non-menstruating female; may allow for 1 repeat test after 7 days of screening, including (but not limited to) females who are menstruating at the time of screening;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the ULN;
- Systolic blood pressure (SBP) outside the range of 90 to 140 mmHg, diastolic blood pressure (DBP) outside the range of 40 to 90 mmHg, and/or pulse rate outside the range of 40 to 100 bpm at screening or check-in. One repeat blood pressure measurement may be performed if SBP is between 141 and 150 mmHg or DBP is between 91 and 95;
- Clinically significant abnormality on ECG in the judgment of the Investigator;
- Reticulocyte value (percent reticulocytes) of more than 1% above the upper limit of normal (ULN) for the reference laboratory;
- Oxygen saturation by pulse oximetry <95%;
- History of clinically significant drug and/or food allergies as determined by the Principal Investigator (PI);
- History of clinically significant cardiac arrhythmia;
- Subject is not willing to abstain from alcohol for 48 hours prior to the start of the first dose until completion of the post-study follow-up assessments; or the average weekly alcohol intake of greater than 21 units or an average daily intake of greater than 3 units (One unit is equivalent to a half-pint of beer or 1 measure of spirits or 1 glass of wine.); recent history (within 2 years) or currently diagnosed alcohol or drug abuse, in the judgement of the Investigator;
- Tobacco or nicotine replacement product use within the 6 months prior to first dose through the follow-up visit, or a positive urine screen for cotinine;
- Hypersensitivity or idiosyncratic reaction to compounds related to the study drug (e.g. sulfite);
- Use of substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 14 days prior to the first dose;
- Use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication;
- Consumption of food or beverage containing grapefruit or cranberry within 7 days prior to the first dose of study medication;
- Donation of whole blood in excess of 500 mL within 30 days prior to check in;
- Plasma donation within 7 days prior to check-in;
- Subject participated in an investigational clinical study within 30 days (of last dose of previous study drug) prior to the first dosing, or within days calculated as 10 times the half-life of the compound that the subject was treated with, whichever is longer or participated in the early cohorts of the current study. Factors other than the half-life of the compound, such as accumulation of tissue, muscle or organ, should also be considered for the enrollment;
- Positive urine screen for drugs of abuse at screening or check-in; or
- Any condition that, in the opinion of the Principal Investigator, would complicate or compromise the study, or the well-being of the subject.
- Any other serious underlying medical conditions (e.g. uncontrolled diabetes mellitus, uncontrolled hypertension, active uncontrolled infection, active gastric ulcer, uncontrolled seizures, cerebrovascular incidents, gastrointestinal bleeding, severe signs and symptoms of coagulation and clotting disorders, cardiac conditions), psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect subject compliance or place the subject at high risk from treatment-related complications.
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
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Y-2(Edaravone And Borneol) sublingual tablet
|
Y-2 sublingual tablet at single ascending doses of one tablet , two tablets, three tablets, four tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 0 hours to 36 hours
|
Any untoward medical events during this study were categorized as severe, moderate, or mild, and related or not related to study treatment
|
0 hours to 36 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration [Cmax]
Time Frame: 0 hours to 24 hours
|
To evaluate Maximum Plasma Concentration [Cmax] of Y-2 in patients tested
|
0 hours to 24 hours
|
Time of Observed Cmax[tmax]
Time Frame: 0 hours to 24 hours
|
To evaluate Time of Observed Cmax[tmax] of Y-2 in patients tested
|
0 hours to 24 hours
|
Area Under the concentration-time Curve from time zero to the last detectable concentration[AUC0-t]
Time Frame: 0 hours to 24 hours
|
To evaluate Area Under the concentration-time Curve from time zero to the last detectable concentration[AUC0-t] of Y-2 in patients tested
|
0 hours to 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
October 25, 2018
Primary Completion (Anticipated)
December 1, 2020
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
March 21, 2018
First Submitted That Met QC Criteria
April 4, 2018
First Posted (Actual)
April 11, 2018
Study Record Updates
Last Update Posted (Actual)
February 17, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Hemorrhage
- Intracranial Hemorrhages
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Neuroprotective Agents
- Protective Agents
- Antioxidants
- Free Radical Scavengers
- Edaravone
Other Study ID Numbers
- Y-2-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Intracranial Hemorrhages
-
King's College Hospital NHS TrustActive, not recruitingStroke | Intracranial Hemorrhages | Brain AneurysmUnited Kingdom
-
Fondation Ophtalmologique Adolphe de RothschildActive, not recruitingPatients' Follow-up After Subarachnoid Haemorrhage Caused by Ruptured Intracranial Aneurysms (FUSAC)Intracranial AneurysmsFrance
-
NoNO Inc.WithdrawnSubarachnoid Hemorrhage | Ruptured Intracranial AneurysmCanada, United States
-
Walton Centre NHS Foundation TrustUniversity of Liverpool; National Institute for Health Research, United KingdomNot yet recruitingTiming to Restart Direct Oral Anticoagulants After Traumatic Intracranial Haemorrhage (RESTARTtlCrH)Traumatic Intracranial Haemorrhage
-
McMaster UniversityCanadian Institutes of Health Research (CIHR)CompletedTraumatic Intracranial HaemorrhageCanada
-
McMaster UniversityCanadian Institutes of Health Research (CIHR)UnknownTraumatic Intracranial HaemorrhageCanada
-
Centre hospitalier de l'Université de Montréal...RecruitingIntracranial Hemorrhage Ruptured AneurysmUnited States, Canada, Spain
-
Alexion Pharmaceuticals, Inc.CompletedAcute Intracranial HemorrhageCanada, Denmark, Italy, Netherlands, Spain, United States, Belgium, Switzerland, Germany, Hungary, Russian Federation, Czechia, France, United Kingdom, Israel, Austria, Norway, Latvia, Finland, Poland, Sweden, Portugal, Greece, Lithuania
-
Henry Ford Health SystemUnknownSubarachnoid Hemorrhage | Vasospasm, Intracranial | Cerebral AneurysmUnited States
-
University of California, Los AngelesCompletedSubarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Cerebral Vasospasm | Intracranial AneurysmUnited States
Clinical Trials on Y-2(Edaravone And Borneol) Sublingual Tablet
-
Peking University Third HospitalCompleted
-
Simcere Pharmaceutical Co., LtdCompleted
-
Beijing Tiantan HospitalNeuroDawn Pharmaceutical Co., Ltd.RecruitingAcute Ischemic Stroke | Large Vessel Occlusion | ReperfusionChina
-
Simcere Pharmaceutical Co., LtdNot yet recruitingPost-stroke Cognitive ImpairmentChina
-
Bispebjerg HospitalLund University; University of Copenhagen; ALK-Abelló A/SCompletedThe Effect of Allergen Immunotherapy on Anti-viral Immunity in Patients With Allergic Asthma (VITAL)Allergic Asthma Due to Dermatophagoides PteronyssinusDenmark
-
Melt PharmaceuticalsCatalent; Evolution Research Group; MedTrials Incorporated; PharmalexNot yet recruiting
-
Stallergenes GreerCompleted
-
Stallergenes GreerCompleted
-
Seoul National UniversityWithdrawnBreakthrough Pain | Cancer Pain
-
Auzone Biological Technology Pty LtdTIGERMED AUSTRALIA PTY LIMITED; CMAX Clinical Research Pty LtdCompleted