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

Phase 1

Completed

• Conditions: Chronic Hepatitis c
• Interventions: Drug: Kangdaprevir Sodium Tablet; Drug: placebo

• Registration Number: NCT03811678
• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2018-01-11
• Primary Completion: 2018-05-29
• Study Completion: 2018-05-29
• Study First Submitted: 2019-01-16
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-22
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-17
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
600 mg single dose	placebo	Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
200 mg single dose	placebo	Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
400 mg single dose	Kangdaprevir Sodium Tablet	Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
400 mg single dose	placebo	Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
800 mg single dose	Kangdaprevir Sodium Tablet	Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
100 mg multiple dose	placebo	Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
800 mg single dose	placebo	Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
50 mg single dose	Kangdaprevir Sodium Tablet	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).
200 mg single dose	Kangdaprevir Sodium Tablet	Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
100 mg multiple dose	Kangdaprevir Sodium Tablet	Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
50 mg single dose	placebo	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).
400 mg multiple dose	Kangdaprevir Sodium Tablet	Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
100 mg single dose	Kangdaprevir Sodium Tablet	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.
100 mg single dose	placebo	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.
200 mg multiple dose	Kangdaprevir Sodium Tablet	Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
600 mg single dose	Kangdaprevir Sodium Tablet	Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
200 mg multiple dose	placebo	Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
400 mg multiple dose	placebo	Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Primary Outcome Measures

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

Trial Locations

Locations (1)

the First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China