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Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114

Sponsor
Sunshine Lake Pharma Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05504876
Collaborator
(none)
14
Enrollment
1
Arm
3.9
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Sep 23, 2022
Anticipated Primary Completion Date :
Oct 23, 2022
Anticipated Study Completion Date :
Jan 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Drug: HEC74647PA
Administered HEC74647PA 100 mg orally once daily in fed state;

Drug: HEC110114
Administered HEC110114 600 mg orally once daily in fed state;

Outcome Measures

Primary Outcome Measures

  1. Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax) [Day 1, Day9]

  2. 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]

  3. 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]

  4. Incidence of adverse eventsECG, or Physical Examination. [Day 1 to Day16]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sunshine Lake Pharma Co., Ltd.

Investigators

  • Principal Investigator: Zhang Hong, Doctor, The First Hospital of Jilin University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunshine Lake Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05504876
Other Study ID Numbers:
  • HEC74647/HEC110114-DDI-101
First Posted:
Aug 17, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Midazolam

Study Results

No Results Posted as of Aug 17, 2022