Back to results

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

Primary Purpose

Chronic Hepatitis c

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Kangdaprevir Sodium Tablet

placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis c

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

the First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Arm Label

50 mg single dose

100 mg single dose

200 mg single dose

400 mg single dose

600 mg single dose

800 mg single dose

100 mg multiple dose

200 mg multiple dose

400 mg multiple dose

Arm Description

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).

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.

Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Outcomes

Primary Outcome Measures

Adverse events

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

Cmax

Maximum observed plasma concentration of HEC84048

Tmax

Time of the maximum observed plasma concentration of HEC84048

AUC

Area under the plasma concentration-time curve (AUC)

T1/2

Terminal elimination half-life

Vz/F

Apparent volume of distribution

CL/F

Oral clearance

MRT

Mean Residence Time

Secondary Outcome Measures

Full Information

NCT ID

NCT03811678

First Posted

January 16, 2019

Last Updated

March 17, 2020

Sponsor

Sunshine Lake Pharma Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03811678

Brief Title

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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

January 11, 2018 (Actual)

Primary Completion Date

May 29, 2018 (Actual)

Study Completion Date

May 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunshine Lake Pharma Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis c

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50 mg single dose

Arm Type

Experimental

Arm Description

Arm Title

100 mg single dose

Arm Type

Experimental

Arm Description

Arm Title

200 mg single dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Arm Title

400 mg single dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Arm Title

600 mg single dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Arm Title

800 mg single dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).

Arm Title

100 mg multiple dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Arm Title

200 mg multiple dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Arm Title

400 mg multiple dose

Arm Type

Experimental

Arm Description

Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.

Intervention Type

Drug

Intervention Name(s)

Kangdaprevir Sodium Tablet

Other Intervention Name(s)

HEC84048Na

Intervention Description

Tablet，administered orally once daily

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

HEC84048Na matching placebo

Intervention Description

Tablet，administered orally once daily

Primary Outcome Measure Information:

Title

Adverse events

Description

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

Time Frame

Baseline to day 13

Title

Cmax

Description

Maximum observed plasma concentration of HEC84048

Time Frame