Study on PK of Hydronidone in Patients and Special Population

NCT04123769 | Completed Phase 1

• 1 other identifier: GNI-F351-201901
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Evaluate the pharmacokinetic (PK) characteristics of Hydronidone capsule in target patients (patients with chronic viral hepatitis b with liver fibrosis) and special population (patients with mild liver dysfunction).
2. 2.To evaluate the effect of oral Hydronidone capsule on QT/QTc in patients with chronic viral hepatitis b accompanied by hepatic fibrosis and mild hepatic dysfunction.

Conditions

Hepatitis b & Liver Dysfunction

Outcome Measures

Primary Outcomes (4)

• Cmax

  up to 24 weeks

• Tmax

  up to 24 weeks

• AUC

  up to 24 weeks

• QT/QTc

  up to 24 weeks

Secondary Outcomes (1)

• CL/F

  up to 24 weeks

Study Arms (1)

Drug group

EXPERIMENTAL

Drug: Hydronidone

Interventions

Hydronidone DRUG

First take Hydronidone capsule, single-dose and then Multiple-dose

Drug group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years (including 18 and 65 years);
• BMI 18-26 (including 18 and 26) \[BMI= weight (kg)/height 2 (m2)\];
• History of chronic hepatitis b, HBsAg positive ≥6 months;
• ALT \< 5 times ULN (standard upper limit);
• TBiL \< 2 times ULN (standard upper limit);
• ALP \< 1.5 times ULN (standard upper limit);
• Liver elastic hardness test confirmed significant liver fibrosis (LSM≥ 7.3kpa);
• Scores assessed by child-pugh system are 5 or 6;
• Patients currently receiving antiviral treatment with entecavir;
• The subject (or his/her partner) has no pregnancy plan during and within 6 months after the trial and voluntarily takes effective physical contraception and has no sperm or egg donation plan;
• Before the trial, I have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks of the trial, and I have volunteered to participate in the clinical trial. I am able to communicate well with the investigator, comply with the requirements of the whole study, and have signed a written informed consent.

You may not qualify if:

• (consultation) participants in clinical trials of other drugs in recent 3 months;
• (consultation) any drugs that inhibit or induce drug metabolism in the liver (common liver enzyme inducers: barbiturates (phenobarbital is the most common), carbamazepine, aminoximate, griseofulvin, aminopropyl ester, phenytoin, gromitol, rifampin, dexamethasone; Common liver enzyme inhibitors: chlorpromazine, cimetidine, ciprofloxacin, metronidazole, chloramphenicol, isoniazid, sulfonamide);
• (consultation) select those who drank excessive amounts of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =250mL) every day during the first three months; Or from the screening to -1 days after admission, intake of any food or drink containing caffeine and xanthine (such as coffee, strong tea, chocolate, etc.) and other special diet that affects the absorption, distribution, metabolism and excretion of drugs;
• (consultation) patients who had taken food or drinks containing enzymes that can induce or inhibit liver metabolism (e.g., grapefruit, mango, pitaya, grape juice, orange juice and other compounds rich in flavonoids or citrus glycosides) before admission were screened.
• (consultation) screening: drinking more than 14 standard units of alcohol per week in the first 3 months (1 standard unit contains 14g of alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine); Or cannot abstain from alcohol during the test period; Or taking any alcohol products within 24 hours before the first dose of the study;
• (consultation) select those who smoke more than 5 cigarettes per day within the first 3 months, or cannot stop using any tobacco products during the trial; Screening for smoking or using any tobacco products up to admission;
• (consultation) previous history of drug abuse and drug abuse;
• (consultation) patients with upper gastrointestinal massive bleeding or active peptic ulcer within the first 3 months were enrolled;
• (consultation) patients with serious diseases of cardiovascular, pulmonary, renal, endocrine, nervous and blood systems and mental disorders;
• (consultation) allergy: if allergic to two or more drugs or food; Lactose intolerant;
• AFP \> 100 μg /L;
• B ultrasound showed obvious space-occupying lesions in the liver, suggesting tumor;
• Patients with decompensated liver cirrhosis;
• Patients with malignant tumors;
• Pregnant and/or lactating women;

Sponsors & Collaborators

• Beijing Continent Pharmaceutical Co, Ltd.: lead

Study Sites (1)

Medical ethics committee of wuhan infectious disease hospital

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Hepatitis B; Liver Diseases

Interventions

hydronidone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 11, 2019
• Study Start: September 3, 2019
• Primary Completion: October 9, 2020
• Study Completion: January 30, 2021
• Last Updated: March 24, 2021

Record last verified: 2021-03

Locations

CN (1)