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

NCT ID: NCT04232514

Last Updated: 2020-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2020-08-22

Brief 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

Detailed 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.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A

Subjects will receive HEC74647 on Day 1\~7 and Day13\~19, co-administration with HEC110114 on Day13\~19.

Group Type: EXPERIMENTAL

HEC74647

Intervention Type: DRUG

Administered HEC74647 200 mg orally once daily in fed state

HEC110114

Intervention Type: DRUG

Administered HEC110114 800 mg orally once daily in fed state

Part B

Subjects will receive HEC110114 on Day 1\~7 and Day13\~19, co-administration with HEC74647 on Day13\~19.

Group Type: EXPERIMENTAL

HEC74647

Intervention Type: DRUG

Administered HEC74647 200 mg orally once daily in fed state

HEC110114

Intervention Type: DRUG

Administered HEC110114 800 mg orally once daily in fed state

Interventions

HEC74647

Administered HEC74647 200 mg orally once daily in fed state

Intervention Type: DRUG

HEC110114

Administered HEC110114 800 mg orally once daily in fed state

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanhua Ding, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

The First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

HEC74647-P-03

Identifier Type: -

Identifier Source: org_study_id