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Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets (GST-HG141)

Primary Purpose

Hepatitis B

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
GST-HG141 tablets
Placebo
Sponsored by
Fujian Cosunter Pharmaceutical Co. Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
  2. Ability to complete research in accordance with test plan requirements;
  3. Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
  4. Male and female healthy subjects aged 18 to 55 years (including 18 and 55 years old);
  5. Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 ~ 28 kg / m2 (including critical value);
  6. Physical examination, normal or abnormal vital signs have no clinical significance.

Exclusion Criteria:

  1. Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
  2. Allergies (multiple drugs and food allergies);
  3. Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
  4. Blood donation or massive blood loss (> 450 mL) within three months before screening;
  5. Take any drug that changes the activity of liver enzymes 28 days before screening;
  6. Took any prescription drugs, over-the-counter drugs, any vitamin products, or herbs within 14 days before screening;
  7. Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or have vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening;
  8. Combined with inhibitors or inducers of CYP3A4, such as itraconazole, ketoconazole, etc.;
  9. Major changes in diet or exercise habits recently;
  10. Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
  11. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption;
  12. Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
  13. Subjects who cannot tolerate a standard meal (two boiled eggs, a piece of buttered bacon toast, a box of fried potato strips, a cup of full-fat milk) (this strip is only applicable to subjects participating in post-meal trials);
  14. Abnormal ECG has clinical significance;
  15. Female subjects were breastfeeding during the screening period or during the trial or were preparing for pregnancy recently or had a positive serum pregnancy result;
  16. Clinical laboratory examinations are abnormal and clinically significant, or the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease);
  17. Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody;
  18. Acute disease or concomitant medication occurs from the screening stage to before study medication;
  19. Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug;
  20. Have taken any alcohol-containing product within 24 hours before taking the study drug;
  21. People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years;
  22. The investigator believes that there are other subjects who are not suitable for participating in this trial.

Sites / Locations

  • The first hospital of Jilin UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Single-dose experimental group

Single-dose control group

Multi-dose experimental group

Multi-dose control group

Food Impact Study Group A

Food Impact Study Group B

Arm Description

50mg, 100mg, 200mg, 300mg, 400mg, 500mg need to complete a single-dose clinical study, each group of 10 subjects, of which 8 received test drugs, 2 received placebo. Each group was administered once, under the fasting condition of Day1, and the tolerance was evaluated on Day2 and Day4. Subjects in different dose groups were enrolled in turn, and the next set of trials was conducted on the premise that the previous set of tolerability assessments were tolerated. The actual completion of the final dose, depending on the test results.

50mg, 100mg, 200mg, 300mg, 400mg, 500mg need to complete a single-dose clinical study, each group of 10 subjects, of which 8 received test drugs, 2 received placebo.

According to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups at 100 mg, 200 mg, 300 mg, and 400 mg. A total of 12 subjects in each dose group, of which 10 received the test drug, 2 received placebo. It is necessary to decide the multiple administration method and dosage according to the result of single administration, which is initially determined to be once a day. After the first dose, Day3, Day6, and Day12 were evaluated for tolerance, and the next group of tests was conducted under the premise that the previous group of Day12 tolerance evaluation was tolerated.

According to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups at 100 mg, 200 mg, 300 mg, and 400 mg. A total of 12 subjects in each dose group, of which 10 received the test drug, 2 received placebo.

Group A was administered under the fasting condition of Day1 in the first cycle, and under the postprandial conditions of Day8 ~ Day15 in the second cycle. Group B was administered under the postprandial conditions of Day1 in the first cycle, and under the sky-abdominal conditions of Day8 ~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days. In group A, the tolerance evaluation was conducted on Day 2 and Day 4 after the first administration. After the first dose of group A is completed and the tolerability evaluation result is considered tolerable, the second cycle of this group and the first cycle of group B can be carried out.

Group A was administered under the fasting condition of Day1 in the first cycle, and under the postprandial conditions of Day8 ~ Day15 in the second cycle. Group B was administered under the postprandial conditions of Day1 in the first cycle, and under the sky-abdominal conditions of Day8 ~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days. In group A, the tolerance evaluation was conducted on Day 2 and Day 4 after the first administration. After the first dose of group A is completed and the tolerability evaluation result is considered tolerable, the second cycle of this group and the first cycle of group B can be carried out.

Outcomes

Primary Outcome Measures

Area Under Curve (AUC)
Plasma samples were collected at different points for pharmacokinetic analysis
Peak Plasma Concentration (Cmax)
Plasma samples were collected at different points for pharmacokinetic analysis
T1/2
Plasma samples were collected at different points for pharmacokinetic analysis
Cl/F
Plasma samples were collected at different points for pharmacokinetic analysis

Secondary Outcome Measures

Ae(0~120h)
Plasma samples were collected at different points for pharmacokinetic analysis
Fe(0~120h)
Plasma samples were collected at different points for pharmacokinetic analysis

Full Information

First Posted
May 7, 2020
Last Updated
June 1, 2020
Sponsor
Fujian Cosunter Pharmaceutical Co. Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04386915
Brief Title
Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets
Acronym
GST-HG141
Official Title
To Evaluate the Tolerability and Pharmacokinetics of GST-HG141 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
August 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fujian Cosunter Pharmaceutical Co. Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To Evaluate the Tolerability and Pharmacokinetics of GST-HG141 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .
Detailed Description
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies. To evaluate the tolerance of GST-HG141 tablets in healthy subjects in single and multiple administrations, pharmacokinetic characteristics, drug metabolism and transformation, and the effect of food on GST-HG141 pharmacokinetics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-dose experimental group
Arm Type
Experimental
Arm Description
50mg, 100mg, 200mg, 300mg, 400mg, 500mg need to complete a single-dose clinical study, each group of 10 subjects, of which 8 received test drugs, 2 received placebo. Each group was administered once, under the fasting condition of Day1, and the tolerance was evaluated on Day2 and Day4. Subjects in different dose groups were enrolled in turn, and the next set of trials was conducted on the premise that the previous set of tolerability assessments were tolerated. The actual completion of the final dose, depending on the test results.
Arm Title
Single-dose control group
Arm Type
Placebo Comparator
Arm Description
50mg, 100mg, 200mg, 300mg, 400mg, 500mg need to complete a single-dose clinical study, each group of 10 subjects, of which 8 received test drugs, 2 received placebo.
Arm Title
Multi-dose experimental group
Arm Type
Experimental
Arm Description
According to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups at 100 mg, 200 mg, 300 mg, and 400 mg. A total of 12 subjects in each dose group, of which 10 received the test drug, 2 received placebo. It is necessary to decide the multiple administration method and dosage according to the result of single administration, which is initially determined to be once a day. After the first dose, Day3, Day6, and Day12 were evaluated for tolerance, and the next group of tests was conducted under the premise that the previous group of Day12 tolerance evaluation was tolerated.
Arm Title
Multi-dose control group
Arm Type
Placebo Comparator
Arm Description
According to the results of the single-dose study, it is planned to carry out multiple-dose studies in 1 to 3 dose groups at 100 mg, 200 mg, 300 mg, and 400 mg. A total of 12 subjects in each dose group, of which 10 received the test drug, 2 received placebo.
Arm Title
Food Impact Study Group A
Arm Type
Experimental
Arm Description
Group A was administered under the fasting condition of Day1 in the first cycle, and under the postprandial conditions of Day8 ~ Day15 in the second cycle. Group B was administered under the postprandial conditions of Day1 in the first cycle, and under the sky-abdominal conditions of Day8 ~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days. In group A, the tolerance evaluation was conducted on Day 2 and Day 4 after the first administration. After the first dose of group A is completed and the tolerability evaluation result is considered tolerable, the second cycle of this group and the first cycle of group B can be carried out.
Arm Title
Food Impact Study Group B
Arm Type
Experimental
Arm Description
Group A was administered under the fasting condition of Day1 in the first cycle, and under the postprandial conditions of Day8 ~ Day15 in the second cycle. Group B was administered under the postprandial conditions of Day1 in the first cycle, and under the sky-abdominal conditions of Day8 ~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days. In group A, the tolerance evaluation was conducted on Day 2 and Day 4 after the first administration. After the first dose of group A is completed and the tolerability evaluation result is considered tolerable, the second cycle of this group and the first cycle of group B can be carried out.
Intervention Type
Drug
Intervention Name(s)
GST-HG141 tablets
Intervention Description
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies.
Primary Outcome Measure Information:
Title
Area Under Curve (AUC)
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.
Title
Peak Plasma Concentration (Cmax)
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.
Title
T1/2
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.
Title
Cl/F
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.
Secondary Outcome Measure Information:
Title
Ae(0~120h)
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.
Title
Fe(0~120h)
Description
Plasma samples were collected at different points for pharmacokinetic analysis
Time Frame
Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 120hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24hours on Day1, more details in protocol.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial; Ability to complete research in accordance with test plan requirements; Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration; Male and female healthy subjects aged 18 to 55 years (including 18 and 55 years old); Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 ~ 28 kg / m2 (including critical value); Physical examination, normal or abnormal vital signs have no clinical significance. Exclusion Criteria: Those who smoked more than 5 cigarettes per day in the 3 months before the trial; Allergies (multiple drugs and food allergies); Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); Blood donation or massive blood loss (> 450 mL) within three months before screening; Take any drug that changes the activity of liver enzymes 28 days before screening; Took any prescription drugs, over-the-counter drugs, any vitamin products, or herbs within 14 days before screening; Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or have vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening; Combined with inhibitors or inducers of CYP3A4, such as itraconazole, ketoconazole, etc.; Major changes in diet or exercise habits recently; Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug; Have a history of dysphagia or any gastrointestinal disease that affects drug absorption; Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers; Subjects who cannot tolerate a standard meal (two boiled eggs, a piece of buttered bacon toast, a box of fried potato strips, a cup of full-fat milk) (this strip is only applicable to subjects participating in post-meal trials); Abnormal ECG has clinical significance; Female subjects were breastfeeding during the screening period or during the trial or were preparing for pregnancy recently or had a positive serum pregnancy result; Clinical laboratory examinations are abnormal and clinically significant, or the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease); Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody; Acute disease or concomitant medication occurs from the screening stage to before study medication; Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug; Have taken any alcohol-containing product within 24 hours before taking the study drug; People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years; The investigator believes that there are other subjects who are not suitable for participating in this trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanan Tang, MD
Phone
+86 13585734994
Email
annie_tyn@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junqi Niu, PHD
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junqi Niu, PHD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets

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