Drug-drug Interaction Study Between HEC74647PA Capsule and HEC110114 Tablets in Healthy Subjects

Chronic Hepatitis C Clinical Trial

Official title:

A Open-label, Single Center Drug Interaction Study Between HEC74647PA Capsule and HEC110114 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04232514
• Other study ID #: HEC74647-P-03
• Status: Completed
• Phase: Phase 1
• Start date: July 15, 2020
• Est. completion date: August 22, 2020

Study information

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

Clinical Trial Summary

The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics (PK) and tolerability of HEC74647 combined with HEC110114 in healthy subjects

Description:

This is a 2-part study with each part is an open-label study in healthy adult subjects.

Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part B), 14 subjects in each part. With each part, the subject will be receive study drug per the defined treatment periods of Day 1~7 and Day 13~19.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 22, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions.

• Be able to complete the study according to the trail protocol.

• Subjects (including partners) have no pregnancy plan within 3 months after the last dose of study drug and voluntarily take effective contraceptive measures.

• Male subjects and must be 18 to 45 years of age inclusive.

• Body weight = 50 kg and body mass index(BMI)between 18 and 28 kg / m2, inclusive.

• Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

• Use of >5 cigarettes per day during the past 3 months.

• Known history of allergy to study drugs,or allergies constitution ( multiple drug and food allergies).

• History of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits or 100 mL of wine).

• Donation or loss of blood over 450 mL within 3 months prior to screening.

• 12-lead ECG with clinically significant.

• Positive for Viral hepatitis (including hepatitis B and C), HIV and syphilis.

• Subjects deemed unsuitable by the investigator for any other reason.

Related Conditions & MeSH terms

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

Intervention

Drug:
• HEC74647
Administered HEC74647 200 mg orally once daily in fed state
• HEC110114
Administered HEC110114 800 mg orally once daily in fed state

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	Incidence of adverse events	From Days 1-26
Primary	Cmax	Maximum plasma concentration of study drugs	Day 7-12 and Day 19-26
Primary	AUC	Maximum plasma concentration of study drugs	Day 7-12 and Day 19-26