Healthy SubjectsPhase 1NCT05504876
Pharmacokinetics of Midazolam When Co-administered With HEC74647 and HEC110114
A Phase 1 study testing Midazolam Syrup, HEC74647PA and HEC110114 in people with Healthy Subjects, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Midazolam Syrup, HEC74647PA and HEC110114
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2022to 13 Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Healthy Subjects
- Being tested
- Midazolam Syrup, HEC74647PA, HEC110114
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam SyrupDrug
Administered Midazolam Syrup 5 mg orally once daily in fed state;
HEC74647PADrug
Administered HEC74647PA 100 mg orally once daily in fed state;
HEC110114Drug
Administered HEC110114 600 mg orally once daily in fed state;
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Midazolam Syrup; Drug: HEC74647PA; Drug: HEC110114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax)
Measured: 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)
Measured: 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-∞)
Measured: Day 1, Day9
Incidence of adverse eventsECG, or Physical Examination.
Measured: Day 1 to Day16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start7 Nov 2022
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhang Hong, Doctor, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05504876
- Sponsor's protocol ID
- HEC74647/HEC110114-DDI-101
- Status last verified
- Nov 2022
- First submitted
- 15 Aug 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05504876
- Acronym / sponsor ID
- HEC74647/HEC110114-DDI-101
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 17 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Midazolam Syrup HEC74647PA HEC110114 | Experimental | Drug: Midazolam Syrup, Drug: HEC74647PA, Drug: HEC110114Subjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midazolam SyrupAdministered Midazolam Syrup 5 mg orally once daily in fed state; | Drug | Midazolam Syrup HEC74647PA HEC110114 |
| HEC74647PAAdministered HEC74647PA 100 mg orally once daily in fed state; | Drug | Midazolam Syrup HEC74647PA HEC110114 |
| HEC110114Administered HEC110114 600 mg orally once daily in fed state; | Drug | Midazolam Syrup HEC74647PA HEC110114 |
Primary outcome
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax)
Time frame: 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)
Time frame: 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-∞)
Time frame: Day 1, Day9
Incidence of adverse eventsECG, or Physical Examination.
Time frame: Day 1 to Day16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhang Hong, Doctor principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam Syrup, HEC74647PA and HEC110114 in people with Healthy Subjects, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Steady-state Oral HEC74647PA and HEC110114 on the Single Dose Pharmacokinetics (PK) of Oral Midazolam in Healthy Subjects (Cmax) (time frame: Day 1, Day9). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.