Safety, Tolerability and Pharmacokinetics of Y-2(Edaravone And Borneol) Sublingual Tablet

NCT03495206 | Unknown Phase 1 FDA Drug

• 1 other identifier: Y-2-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke, Acute; Intracranial Hemorrhages

Outcome Measures

Primary Outcomes (1)

• Number of participants who experience treatment-related adverse events (AEs) and serious adverse events (SAEs)

  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 Outcomes (3)

• Maximum Plasma Concentration [Cmax]

  0 hours to 24 hours

• Time of Observed Cmax[tmax]

  0 hours to 24 hours

• Area Under the concentration-time Curve from time zero to the last detectable concentration[AUC0-t]

  0 hours to 24 hours

Study Arms (1)

Y-2(Edaravone And Borneol) sublingual tablet

EXPERIMENTAL

Drug: Y-2(Edaravone And Borneol) Sublingual Tablet

Interventions

Y-2(Edaravone And Borneol) Sublingual Tablet DRUG

Y-2 sublingual tablet at single ascending doses of one tablet , two tablets, three tablets, four tablets

Y-2(Edaravone And Borneol) sublingual tablet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yantai YenePharma Co., Ltd.: lead

Study Sites (1)

OSF Healthcare System d/b/a Saint Francis Medical

Peoria, Illinois, 61637, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Intracranial Hemorrhages

Interventions

isoborneol; Administration, Sublingual

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Administration, Oral; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

David Z. Wang, M.D.

CONTACT

(309) 624-9500; david.wang@chinastroke.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: April 11, 2018
• Study Start: October 25, 2018
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (1)