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Completed

NCT Number: NCT04201275

The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects

The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

About this study

All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points during the study.All subjects also will be monitored for up to 8 days post-dose to determine the persistence of viral mutations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to comprehend and sign the ICF voluntarily prior to initiate the study;
  • Able to complete the study according to the protocol;
  • Agree to use protocol defined precautions against pregnancy
  • Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 30 kg/m2, inclusive;
  • HCV treatment-naïve adult subjects with GT1-6 HCV infection
  • HCV RNA level ≥ 5 log10 IU/mL at screening
  • FibroScan score within 6 months≤12.5 kPa or Liver biopsy results within 12 months proved Non-cirrhosis

Exclusion criteria

  • Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
  • Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
  • Donated blood or massive blood loss within 3 months before screening (>450 mL）;
  • Have any disease that increases the risk of bleeding, such as acute gastritis or stomach and duodenal ulcers;
  • Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
  • Have taken any drug that inhibit gastric acid secretion, such as H2 receptor antagonist famotidine and proton pump inhibitor omeprazole;
  • Have participated in any clinical trial or taken any study drug within 3 months before dosing;
  • Positive test result of HBV,HIV or syphilis;
  • Solid organ transplanters

Treatment and study plan

HEC74647PA Capsule

Drug

Capsule administered orally once daily

Placebo

Drug

HEC74647PA capsule matching placebo administered orally once daily

Primary outcomes

  1. Adverse Events,laboratory abnormalities and other abnormalities

    Time frame: 8 days

    Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647

  2. Antiviral Activity

    Time frame: 8 days

    Change from baseline in HCV RNA following dose administration of HEC74647

  3. Sequence changes in the NS5A coding region

    Time frame: 8 days

    Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter

  4. Cmax

    Time frame: 8 days

    Maximum observed plasma concentration of HEC74647

  5. Tmax

    Time frame: 8 days

    Time of the maximum observed plasma concentration

  6. AUC

    Time frame: 8 days

    Area under the plasma concentration-time curve (AUC)

  7. t1/2

    Time frame: 8 days

    Terminal elimination half-life

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

A Single-center, Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Consecutive Dose Study to Assess the Tolerability, Pharmacokinetics and Pharmacodynamics of HEC74647 in Subjects With Chronic Hepatitis C Virus Infection

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2019
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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