Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504876
• Other study ID #: HEC74647/HEC110114-DDI-101
• Status: Completed
• Phase: Phase 1
• Start date: November 7, 2022
• Est. completion date: December 13, 2022

Study information

• Verified date: November 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 13, 2022
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Midazolam Syrup
Administered Midazolam Syrup 5 mg orally once daily in fed state;
• HEC74647PA
Administered HEC74647PA 100 mg orally once daily in fed state;
• HEC110114
Administered HEC110114 600 mg orally once daily in fed state;

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax)		Day 1, Day9
Primary	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
Primary	Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0- 0-8)		Day 1, Day9
Primary	Incidence of adverse eventsECG, or Physical Examination.		Day 1 to Day16