Status:
COMPLETED
Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers
Lead Sponsor:
Sinew Pharma Inc.
Conditions:
Nonalcoholic Steatohepatitis
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
Brief Summary
Fasting Period: At least 10 hours prior to dosing until 4 hours post-dose of each study period. Period: 24 hours post dose in each period. Each subject will complete two study periods. Washout Perio...
Detailed Description
This study is a single center and open-label design to evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after single oral administration in healthy subjects under fasting condit...
Eligibility Criteria
Inclusion
- Normal healthy adult subjects between 20-50 years of age.
- Acceptable medical history and physical examination including:
- Acceptable clinical laboratory determinations without significant deviation from normal values within two months prior to Period I dosing, which includes AST (SGOT), ALT (SGPT), r-GT, alkaline phosphatase, total bilirubin, albumin, glucose, BUN, uric acid, creatinine, total cholesterol, triglyceride (TG) and galactose single point (GSP).
- Acceptable hematology within two months prior to the study, which includes hemoglobin, hematocrit, red blood cells, MCV, MCH, MCHC, white blood cells, differential white blood cells and platelets.
- Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
- Signed the written informed consent to participate in this study.
- Acceptable body mass index (BMI): 18.5 \< BMI \< 25 kg/m2
Exclusion
- Recent history of drug or alcohol addiction or abuse within the past year.
- A clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine or neurologic system(s) or psychiatric disease (as determined by the clinical investigator).
- History of allergic response(s) to mannitol, sucralose or related drugs.
- History of clinically significant allergies including drug allergies or allergic bronchial asthma.
- Evidence of chronic or acute infectious diseases.
- Any clinically significant illness or surgery during the one month prior to Period I dosing (as determined by the clinical investigator).
- Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
- Receiving any investigational drug within one month prior to Period I dosing.
- Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
- Donating greater than 150 mL of blood within two months prior to Period I dosing or donating plasma (e.g. plasmapheresis) within two weeks prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Consumption of caffeine, xanthine-containing products (i.e. coffee, tea, caffeine-containing sodas, colas and chocolate, etc.) and/or alcohol, smoke or use tobacco products within 48 hours prior to days on which dosing is scheduled and during the periods when blood samples are being collected.
- Any other medical reason as determined by the clinical investigator.
- Subject is pregnant or breastfeeding.
- Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
Key Trial Info
Start Date :
May 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05983328
Start Date
May 10 2016
End Date
February 9 2018
Last Update
August 9 2023
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Taiwan, 114