Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of GST-HG131 Tablets

Hepatitis B Clinical Trial

Official title:

To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499443
• Other study ID #: GST-HG131-20-02
• Status: Recruiting
• Phase: Phase 1
• Start date: August 18, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: July 2020
• Source: Fujian Cosunter Pharmaceutical Co. Ltd
• Contact: Yanan Tang, MD
• Phone: +86 13585734994
• Email: annie_tyn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects

Description:

This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100mg, 150 mg, 200 mg, 250 mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies. To evaluate the tolerance of GST-HG131 tablets in healthy subjects in single and multiple administrations, pharmacokinetic characteristics, drug metabolism and transformation, and the effect of food on GST-HG131 pharmacokinetics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: May 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis B

Intervention

Drug:
• GST-HG131 tablets
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.
• Placebo
This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.

Locations

Country	Name	City	State
China	The first hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cosunter Pharmaceutical Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Plasma samples were collected at different points for pharmacokinetic analysis	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.
Primary	Area Under Curve (AUC)	Plasma samples were collected at different points for pharmacokinetic analysis	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.
Primary	T1/2	Plasma samples were collected at different points for pharmacokinetic analysis	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.
Primary	Cl/F	Plasma samples were collected at different points for pharmacokinetic analysis	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	Ae(0~120h)	Plasma samples were collected at different points for pharmacokinetic analysis	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	Fe(0~120h)	Plasma samples were collected at different points for pharmacokinetic analysis	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.