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CompletedNCT05983328Updated Aug 9, 2023

Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers

A Phase 1 interventional study of HUYPS-1 one tablet and HUYPS-1 nine tablets in Nonalcoholic Steatohepatitis, sponsored by Sinew Pharma Inc.. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-09.

Sponsored by Sinew Pharma Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled May 2016, registered Mar 2018).
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
All
01

Study 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.

Read the 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 conditions. A total of 14 eligible subjects are expected to be enrolled to ensure 12 evaluable subjects. The study will be completed when there are at least 12 evaluable subjects. The evaluable subjects are those who have completed both periods. Eligible subjects will be randomly assigned to either of the two treatment sequences.

The study design in a 2-sequence, 2-period crossover design. There is at least 7-day washout time between periods. The formulation of HUYPS-1 for oral administration contains 100 mg mannitol and 100 mg sucralose per tablet will be given by one or nine tablets per person of each period. Mannitol and sucralose are both commonly used excipients approved by WHO. These excipients are included in the FDA Inactive Ingredients Guide, GRAS (generally recognized as safe) and commonly used pharmaceutical excipients, therefore the oral doses of these excipients can be regarded as extremely safe in this study.

02

Conditions studied

  • Nonalcoholic Steatohepatitis
03

In context

Non-alcoholic Fatty Liver Disease

1,507 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.

This study's enrollment of 14 is below the median of 60 across 1,098 interventional studies indexed under Non-alcoholic Fatty Liver Disease.

Browse Non-alcoholic Fatty Liver Disease studies →

Lead sponsor

Sinew Pharma Inc. is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Normal healthy adult subjects between 20-50 years of age.
  2. Acceptable medical history and physical examination including:
  3. 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).
  4. 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.
  5. Acceptable urinalysis within two months prior to the study, which includes pH, blood, glucose and protein.
  6. Signed the written informed consent to participate in this study.
  7. Acceptable body mass index (BMI): 18.5 \< BMI \< 25 kg/m2

Exclusion criteria

Exclusion Criteria:

  1. Recent history of drug or alcohol addiction or abuse within the past year.
  2. 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).
  3. History of allergic response(s) to mannitol, sucralose or related drugs.
  4. History of clinically significant allergies including drug allergies or allergic bronchial asthma.
  5. Evidence of chronic or acute infectious diseases.
  6. Any clinically significant illness or surgery during the one month prior to Period I dosing (as determined by the clinical investigator).
  7. Taking any drug known to induce or inhibit hepatic drug metabolism within one month prior to the beginning of the study.
  8. Receiving any investigational drug within one month prior to Period I dosing.
  9. Taking any prescription medication or any nonprescription medication within two weeks prior to Period I doing.
  10. 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.
  11. 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.
  12. Any other medical reason as determined by the clinical investigator.
  13. Subject is pregnant or breastfeeding.
  14. Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Healthy Volunteers dose 1

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

    Drug: HUYPS-1 one tablet

  • Experimental
    Healthy Volunteer dose 2

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

    Drug: HUYPS-1 nine tablets

Interventions

  • DrugHUYPS-1 one tablet

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

  • DrugHUYPS-1 nine tablets

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

06

What researchers measure

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.

    Time frame: 24 hours

Secondary outcomes

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

    Concentrations of HUYPS-1 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: Cmax

    Time frame: 24 hours

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

    Concentrations of HUYPS-1 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: Tmax

    Time frame: 24 hours

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

    Concentrations of HUYPS-1 and it metabolites in plasma and urine will be measured by a specific and sensitive LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: AUC0-t

    Time frame: 24 hours

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

    LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: AUCINF

    Time frame: 24 hours

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

    LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: k

    Time frame: 24 hours

  6. Pharmacokinetic profile of elimination half-life (T1/2) for HUYPS-1

    LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: T1/2

    Time frame: 24 hours

  7. Pharmacokinetic profile of mean residence time (MRT) for HUYPS-1

    LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: MRT

    Time frame: 24 hours

  8. Pharmacokinetic profile of clearance (CL/F) for HUYPS-1

    LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: CL/F

    Time frame: 24 hours

  9. Pharmacokinetic profile of apparent volume (Vd/F) for HUYPS-1

    LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: Vd/F

    Time frame: 24 hours

  10. Pharmacokinetic profile of area under moment curve (AUMC(0-t)) for HUYPS-1

    LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: AUMC(0-t)

    Time frame: 24 hours

  11. Pharmacokinetic profile of area under moment curve infinity (AUMCINF) for HUYPS-1

    LC/MS/MS method developed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. According to the pharmacokinetic parameters of HUYPS-1 and its metabolites in health subjects oral HUYPS-1 to assess the safety information.The study will be conducted to validate the precision, accuracy (including with-run and between-run variation), linearity, specificity, reproducibility, limit of quantitation based on recovery studies. Assays will be performed in the laboratory of Clinical Pharmacokinetic Laboratory of Tri-Service General Hospital. Spiked samples of known concentrations will be analyzed together for quality control of the assay method. The following parameters of HUYPS-1 will be determined using WINNONLINTM: AUMCINF

    Time frame: 24 hours

07

Study locations

1 site
  • Tri-Service General Hospital
    Taipei, 114, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2016 to primary completion in May 2016, 0 months.

Of 94 industry-sponsored phase 1 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's 0 months is below that.

Counting every sponsor, half of 116 studies reached it within 11 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Aug 9, 2023
StartActual
May 10, 2016
Primary completionActual
May 26, 2016
CompletionActual
Feb 9, 2018
Last update
Aug 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05983328
Lead sponsor
Sinew Pharma Inc.
Responsible party
Sponsor
First posted
Aug 9, 2023
Start date
May 10, 2016
Primary completion
May 26, 2016
Completion
Feb 9, 2018
Last update
Aug 9, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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