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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: HEC74647
* Drug: HEC110114


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A<br>Subjects will receive HEC74647 on Day 1 7 and Day13 19, co-administration with HEC110114 on Day13 19. | Drug: HEC74647<br>* Administered HEC74647 200 mg orally once daily in fed state<br>Drug: HEC110114<br>* Administered HEC110114 800 mg orally once daily in fed state<br>|
| Experimental: Part B<br>Subjects will receive HEC110114 on Day 1 7 and Day13 19, co-administration with HEC74647 on Day13 19. | Drug: HEC74647<br>* Administered HEC74647 200 mg orally once daily in fed state<br>Drug: HEC110114<br>* Administered HEC110114 800 mg orally once daily in fed state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of adverse events | From Days 1-26 | 
| Cmax | Maximum plasma concentration of study drugs | Day 7-12 and Day 19-26 | 
| AUC | Maximum plasma concentration of study drugs | Day 7-12 and Day 19-26 |