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

NCT03811678 | Completed Phase 1

• 1 other identifier: PCD-DHEC84048-17-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (9)

50 mg single dose

EXPERIMENTAL

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; Drug: placebo

100 mg single dose

EXPERIMENTAL

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; Drug: placebo

200 mg single dose

EXPERIMENTAL

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

Drug: Kangdaprevir Sodium Tablet; Drug: placebo

400 mg single dose

EXPERIMENTAL

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

Drug: Kangdaprevir Sodium Tablet; Drug: placebo

600 mg single dose

EXPERIMENTAL

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

Drug: Kangdaprevir Sodium Tablet; Drug: placebo

800 mg single dose

EXPERIMENTAL

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

Drug: Kangdaprevir Sodium Tablet; Drug: placebo

100 mg multiple dose

EXPERIMENTAL

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; Drug: placebo

200 mg multiple dose

EXPERIMENTAL

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; Drug: placebo

400 mg multiple dose

EXPERIMENTAL

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; Drug: placebo

Interventions

Kangdaprevir Sodium Tablet DRUG

Tablet，administered orally once daily

Also known as: HEC84048Na

100 mg multiple dose; 100 mg single dose; 200 mg multiple dose; 200 mg single dose; 400 mg multiple dose; 400 mg single dose; 50 mg single dose; 600 mg single dose; 800 mg single dose

placebo DRUG

Tablet，administered orally once daily

Also known as: HEC84048Na matching placebo

100 mg multiple dose; 100 mg single dose; 200 mg multiple dose; 200 mg single dose; 400 mg multiple dose; 400 mg single dose; 50 mg single dose; 600 mg single dose; 800 mg single dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ding Yanhua, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2019
• First Posted: January 22, 2019
• Study Start: January 11, 2018
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)