Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

NCT ID: NCT05504876

Last Updated: 2022-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2022-12-13

Brief Summary

This is a single center, open-label study to investigate whether HEC74647 and HEC110114 has an effect on the pharmacokinetic (PK) profile of midazolam（a cytochrome (CYP) 3A4 substrate）in healthy subjects

Detailed Description

This is a single center, open-label study in healthy adult subjects. Total 14 subjects will be enrolled into the study and will be receive study drug per the defined treatment.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Midazolam Syrup HEC74647PA HEC110114

Subjects will receive 5mg Midazolam Syrup on Day 1,100 mg HEC74647PA and 600 mg HEC110114 on Day3\~8, 5mg Midazolam Syrup co-administered with 100 mg HEC74647PA and 600 mg HEC110114 on Day9.

Group Type: EXPERIMENTAL

Midazolam Syrup

Intervention Type: DRUG

Administered Midazolam Syrup 5 mg orally once daily in fed state;

HEC74647PA

Intervention Type: DRUG

Administered HEC74647PA 100 mg orally once daily in fed state;

HEC110114

Intervention Type: DRUG

Administered HEC110114 600 mg orally once daily in fed state;

Interventions

Midazolam Syrup

Administered Midazolam Syrup 5 mg orally once daily in fed state;

Intervention Type: DRUG

HEC74647PA

Administered HEC74647PA 100 mg orally once daily in fed state;

Intervention Type: DRUG

HEC110114

Administered HEC110114 600 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.
• Must be male or female between 18 to 45 years of age inclusive.
• Male and female should weigh no less than 50 kg and 45 kg respectively, 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: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunshine Lake Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhang Hong, Doctor

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

First Hospital of Jilin University

Changchun, Jilin, China

Countries

China

Other Identifiers

HEC74647/HEC110114-DDI-101

Identifier Type: -

Identifier Source: org_study_id