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

Chronic Hepatitis c Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811678
• Other study ID #: PCD-DHEC84048-17-01
• Status: Completed
• Phase: Phase 1
• Start date: January 11, 2018
• Est. completion date: May 29, 2018

Study information

• Verified date: March 2020
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 29, 2018
• Est. primary completion date: May 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis c
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Kangdaprevir Sodium Tablet
Tablet,administered orally once daily
• placebo
Tablet,administered orally once daily

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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