Phase I Pharmacokinetic Study of HUYPS-1 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-10

Study Completion Date

2018-02-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nonalcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers dose 1

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

Group Type EXPERIMENTAL

HUYPS-1 one tablet

Intervention Type DRUG

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

Healthy Volunteer dose 2

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

Group Type EXPERIMENTAL

HUYPS-1 nine tablets

Intervention Type DRUG

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

Interventions

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HUYPS-1 one tablet

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

Intervention Type DRUG

HUYPS-1 nine tablets

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

Intervention Type DRUG

Eligibility Criteria

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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

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes