Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

NCT05504876 | Completed Phase 1

• 1 other identifier: HEC74647/HEC110114-DDI-101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Midazolam Syrup HEC74647PA HEC110114

EXPERIMENTAL

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.

Drug: Midazolam Syrup; Drug: HEC74647PA; Drug: HEC110114

Interventions

Midazolam Syrup DRUG

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

Midazolam Syrup HEC74647PA HEC110114

HEC74647PA DRUG

Administered HEC74647PA 100 mg orally once daily in fed state;

Midazolam Syrup HEC74647PA HEC110114

HEC110114 DRUG

Administered HEC110114 600 mg orally once daily in fed state;

Midazolam Syrup HEC74647PA HEC110114

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sunshine Lake Pharma Co., Ltd.: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Study Officials

• Zhang Hong, Doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 17, 2022
• Study Start: November 7, 2022
• Primary Completion: December 13, 2022
• Study Completion: December 13, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-11

Locations

CN (1)