The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects

Chronic Hepatitis C Clinical Trial

Official title:

A Single-center, Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Consecutive Dose Study to Assess the Tolerability, Pharmacokinetics and Pharmacodynamics of HEC74647 in Subjects With Chronic Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201275
• Other study ID #: HEC74647-P-02
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2019
• Est. completion date: January 21, 2020

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 goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.

Description:

All subjects will be receive QD doses of HEC74647 or the matching placebo for 3 days to assess the the tolerability, pharmacokinetics and antiviral activity at specified time-points during the study.All subjects also will be monitored for up to 8 days post-dose to determine the persistence of viral mutations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 21, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 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;

• Agree to use protocol defined precautions against pregnancy

• Body weight of male and female subject should be =50 kg and =45 kg respectively; Body Mass Index (BMI) is between 18 and 30 kg/m2, inclusive;

• HCV treatment-naïve adult subjects with GT1-6 HCV infection

• HCV RNA level = 5 log10 IU/mL at screening

• FibroScan score within 6 months=12.5 kPa or Liver biopsy results within 12 months proved Non-cirrhosis

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 acute gastritis or stomach and duodenal ulcers;

• Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;

• Have taken any drug that inhibit gastric acid secretion, such as H2 receptor antagonist famotidine and proton pump inhibitor omeprazole;

• Have participated in any clinical trial or taken any study drug within 3 months before dosing;

• Positive test result of HBV,HIV or syphilis;

• Solid organ transplanters

Related Conditions & MeSH terms

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

Intervention

Drug:
• HEC74647PA capsule
Capsule administered orally once daily
• placebo
HEC74647PA capsule matching placebo 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,laboratory abnormalities and other abnormalities	Number of participants with Adverse Events, laboratory abnormalities and other abnormalities following dose administration of HEC74647	8 days
Primary	Antiviral Activity	Change from baseline in HCV RNA following dose administration of HEC74647	8 days
Primary	Sequence changes in the NS5A coding region	Sequence changes in the NS5A coding region of HCV following multiple dose administration of HEC74647 and for up to 8 days thereafter	8 days
Primary	Cmax	Maximum observed plasma concentration of HEC74647	8 days
Primary	Tmax	Time of the maximum observed plasma concentration	8 days
Primary	AUC	Area under the plasma concentration-time curve (AUC)	8 days
Primary	t1/2	Terminal elimination half-life	8 days