Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers

NCT05983328 | Completed Phase 1

• 1 other identifier: Oral HUYPS-1-001
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 Period: At least one week after dosing of the previous period. Confinement: From at least 10 hours prior to dosing until at least 12 hours post-dose, for a total of at least 22 hours for each study period.

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs):

  An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  24 hours

Secondary Outcomes (11)

• Pharmacokinetic profile of maximum concentration of HUYPS-1 (Cmax)

  24 hours

• Pharmacokinetic profile of time of occurrence for maximum (peak) HUYPS-1 concentration (Tmax)

  24 hours

• Pharmacokinetic profile of area under curve (AUC0-t) for HUYPS-1

  24 hours

• Pharmacokinetic profile of area under curve infinity (AUCINF) for HUYPS-1

  24 hours

• Pharmacokinetic profile of overall HUYPS-1 elimination rate constant (k)

  24 hours

Study Arms (2)

Healthy Volunteers dose 1

EXPERIMENTAL

Evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 1 tablet oral administration in healthy subjects

Drug: HUYPS-1 one tablet

Healthy Volunteer dose 2

EXPERIMENTAL

Evaluate tolerability, safety and pharmacokinetic properties of HUYPS-1 after 9 tablets oral administration in healthy subjects

Drug: HUYPS-1 nine tablets

Interventions

HUYPS-1 one tablet DRUG

After 7-day washout time, subjects will receive HUYPS-1 1 tablet.

Healthy Volunteers dose 1

HUYPS-1 nine tablets DRUG

After 7-day washout time, subjects will receive HUYPS-1 9 tablets.

Healthy Volunteer dose 2

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinew Pharma Inc.: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

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

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: August 9, 2023
• Study Start: May 10, 2016
• Primary Completion: May 26, 2016
• Study Completion: February 9, 2018
• Last Updated: August 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)