Clinical trial NCT05504876: Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax)
timeFrame: Day 1, Day9
measure: Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0-t)
timeFrame: Day 1, Day9
measure: Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (AUC0- 0-∞)
timeFrame: Day 1, Day9
measure: Incidence of adverse eventsECG, or Physical Examination.
timeFrame: Day 1 to Day16
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Zhang Hong, Doctor
role: PRINCIPAL_INVESTIGATOR
References: