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

Sunshine Lake Pharma

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: HEC74647; Drug: HEC110114

Study type: Interventional

Funder types: Industry

Identifiers

NCT04232514

HEC74647-P-03

Details and patient eligibility

About

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

Full 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.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Part A

Experimental group

Description:

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

Treatment:

Drug: HEC110114

Drug: HEC74647

Part B

Experimental group

Description:

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

Treatment:

Drug: HEC110114

Drug: HEC74647