Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

A Single-center, Open-label Study to Investigate the Effect of a Single Oral Dose of HEC74647 and HEC110114 on the Pharmacokinetics of Midazolam, and Their Metabolites in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05504876

Enrollment

Registered

2022-08-17

Start date

2022-11-07

Completion date

2022-12-13

Last updated

2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

Interventions

DRUGMidazolam Syrup

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

DRUGHEC74647PA

Administered HEC74647PA 100 mg orally once daily in fed state;

DRUGHEC110114

Administered HEC110114 600 mg orally once daily in fed state;

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax)	Day 1, Day9
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0-t)	Day 1, Day9
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0- 0-∞)	Day 1, Day9
Incidence of adverse eventsECG, or Physical Examination.	Day 1 to Day16

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026