Skip to main content
OpenTrials
Completed

NCT Number: NCT03811678

The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Completed

Looking for future studies?

Notify Me

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–45 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

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Who can participate

Healthy volunteers accepted: Yes

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;
  • Between 18 and 45 years of age（18 and 45 are inclusive）;
  • Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）;
  • Physical examination and vital signs without clinically significant abnormalities.

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 acne, acute gastritis or stomach and duodenal ulcers;
  • Have take any drug that changes liver enzyme activity within 1 month before taking the study drug
  • Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
  • Have participated in any clinical trial or taken any study drug within 3 months before dosing;
  • Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
  • Have taken any alcoholic products within 24 hours prior to taking the study drug

Treatment and study plan

Kangdaprevir Sodium Tablet

Drug

Tablet，administered orally once daily

Other names: HEC84048Na

Placebo

Drug

Tablet，administered orally once daily

Other names: HEC84048Na matching placebo

Primary outcomes

  1. Adverse events

    Time frame: Baseline to day 13

    To assess the tolerability after a single and multiple dose of HEC84048

  2. Cmax

    Time frame: predose to 72 hour after dosing

    Maximum observed plasma concentration of HEC84048

  3. Tmax

    Time frame: predose to 72 hour after dosing

    Time of the maximum observed plasma concentration of HEC84048

  4. AUC

    Time frame: predose to 72 hour after dosing

    Area under the plasma concentration-time curve (AUC)

  5. T1/2

    Time frame: predose to 72 hour after dosing

    Terminal elimination half-life

  6. Vz/F

    Time frame: predose to 72 hour after dosing

    Apparent volume of distribution

  7. CL/F

    Time frame: predose to 72 hour after dosing

    Oral clearance

  8. MRT

    Time frame: predose to 72 hour after dosing

    Mean Residence Time

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 22, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.