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

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Hepatitis c
• Intervention / Treatment: Drug: Kangdaprevir Sodium Tablet; Drug: placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 mg single dose; It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo
Experimental: 100 mg single dose; Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo
Experimental: 200 mg single dose; Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo
Experimental: 400 mg single dose; Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo
Experimental: 600 mg single dose; Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo
Experimental: 800 mg single dose; Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo
Experimental: 100 mg multiple dose; Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo
Experimental: 200 mg multiple dose; Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo
Experimental: 400 mg multiple dose; Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.	Drug: Kangdaprevir Sodium Tablet; Tablet，administered orally once daily; Other Names: HEC84048Na; Drug: placebo; Tablet，administered orally once daily; Other Names: HEC84048Na matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	To assess the tolerability after a single and multiple dose of HEC84048	Baseline to day 13
Cmax	Maximum observed plasma concentration of HEC84048	predose to 72 hour after dosing
Tmax	Time of the maximum observed plasma concentration of HEC84048	predose to 72 hour after dosing
AUC	Area under the plasma concentration-time curve (AUC)	predose to 72 hour after dosing
T1/2	Terminal elimination half-life	predose to 72 hour after dosing
Vz/F	Apparent volume of distribution	predose to 72 hour after dosing
CL/F	Oral clearance	predose to 72 hour after dosing
MRT	Mean Residence Time	predose to 72 hour after dosing

Collaborators and Investigators

• Sponsor: Sunshine Lake Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Actual): May 29, 2018
• Study Completion (Actual): May 29, 2018

Study Registration Dates

• First Submitted: January 16, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: PCD-DHEC84048-17-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No