QT Interval, Variation inPhase 1NCT06822153
Clinical Trial of the Effect of Methoxyethyl Etomidate Hydrochloride on the QT Interval of the Heart
A Phase 1 study testing ET-26 0.8mg/kg(low-dose) group and ET-26 2.8mg/kg(high dose) group in people with QT Interval, Variation in, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A single intravenous injection of 0.8mg/kg or 2.8mg/kg Et-26-hcl was given to 18 subjects. The effect of plasma concentration on QT interval was evaluated by C-QTc effect model, and the pharmacokinetic characteristics and safety of ET-26 and etomidate acid were evaluated. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- QT Interval, Variation in
- What is being tested?
- ET-26 0.8mg/kg(low-dose) group and ET-26 2.8mg/kg(high dose) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2023to 21 Nov 2023
- 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
- Healthy adult male and female subjects;
- Age: 18-45 years old;
- Body weight: body mass index (BMI) between 19.0 and 28.0 kg/m2, with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
- voluntarily sign informed consent;
- Subjects were able to communicate well with investigators and complete the trial in accordance with the protocol.
Who cannot join
- -
- Auxiliary examination:
- those with clinically significant abnormalities in comprehensive physical examination, vital signs, and laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, serum cortisol);
- potentially difficult airway (modified Mallampati score III-IV);
- abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia as judged by the investigator;
- clinically significant abnormal 12-lead ECG, QTcF≥450 ms, PR interval ≥200 ms, QRS complex duration ≥120ms;
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- hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- Medication history:
- use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 30 days before screening (see Appendix 1 for details);
- Use of any known QT-prolonging medication within 30 days before screening (see Appendix 1 for details);
- use of any prescribed medication within 14 days before dose;
- use of over-the-counter medications, Chinese herbal medicines, or food supplements such as vitamins and calcium supplements within 7 days before administration;
- History of disease and surgery:
- have a history of any clinically serious diseases or diseases or conditions considered by the investigators to be likely to affect the results of the trial, including but not limited to a history of circulatory, respiratory, endocrine, nervous, digestive, urinary, or hematologic, immune, psychiatric, or metabolic diseases;
- with a history of adrenal insufficiency, adrenal tumors, or hereditary heme biosynthesis disorders;
- a history of severe cardiovascular disease, including but not limited to organic heart disease, such as heart failure, myocardial infarction, angina pectoris, or malignant arrhythmia, as judged by the investigator; Such as a history of torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome or symptoms of long QT syndrome and family history (as indicated by genetic evidence or sudden death of a close relative at a young age due to cardiac causes);
- underwent any surgery within 6 months before screening;
- allergic constitution, such as known allergic history to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
- Living habits:
- heavy drinking or regular drinking in the 6 months before screening, i.e. drinking more than 14 units of alcohol per week (1 unit =360 mL of beer or 45 mL of 40% spirits or 150 mL of wine); Or with a positive alcohol breath test during the screening period;
- used nicotine-containing products between 3 months before screening and study enrollment;
- with drug abuse or drug abuse history within 3 months before screening; Or the urine drug test was positive in the screening period;
- habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and inability to quit during the trial;
- Others:
- who had difficulty in blood collection or could not tolerate blood collection by venipuncture;
- participated in any other clinical trial (including drug and device clinical trials) within 3 months before screening;
- vaccinated within 1 month before screening or planned to be vaccinated during the trial period;
- pregnant or lactating women;
- during the trial and within half a year after the completion of the trial, or those who do not agree that the subjects and their spouses should take strict contraceptive measures during the trial and within half a year after the completion of the trial (see Appendix 4 for details);
- had blood loss or donation > 400 mL within 3 months before screening, or received blood transfusion within 1 month;
- had any factors considered by the investigator to preclude participation in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Open-label, Placebo-controlled Phase I Clinical Trial Was Conducted to Evaluate the Pharmacokinetics and QT Interval Effects of a Single Intravenous Injection of Methoxyethyl Etomidate Hydrochloride in Healthy Subjects
A single intravenous injection of 0.8mg/kg or 2.8mg/kg Et-26-hcl was given to 18 subjects. The effect of plasma concentration on QT interval was evaluated by C-QTc effect model, and the pharmacokinetic characteristics and safety of ET-26 and etomidate acid were evaluated.
- Conditions
- QT Interval, Variation in
- Being tested
- ET-26 0.8mg/kg(low-dose) group, ET-26 2.8mg/kg(high dose) group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET-26 0.8mg/kg(low-dose) groupDrug
In a 2:1 ratio, Placebo was administered with normal saline and ET-26 0.8mg/kg for a duration of 60 ±5 seconds.
ET-26 2.8mg/kg(high dose) groupDrug
In a 2:1 ratio, Placebo was administered with normal saline and ET-26 2.8mg/kg for a duration of 60 ±5 seconds.
| Study group | Role | What they receive |
|---|---|---|
| low-dose group | Other | Placebo+ET-26 0.8mg/kg Receives: Drug: ET-26 0.8mg/kg(low-dose) group |
| High dose group | Other | Placebo+ET-26 2.8mg/kg Receives: Drug: ET-26 2.8mg/kg(high dose) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Cmax
Measured: from 1 hour before administration of et-26 until 24 hours after the end of administration.
Secondary outcomes (2)
MOAA/S
modified observer's assessment of alert（MOAA/S） score: The lowest score was 0, indicating full anesthetic sedation, and the highest score was 5, indicating full consciousness.
Measured: up to 10 minutes after drug administration
Eyelash reflex
Gently touching the subject's eyelashes with a cotton swab can cause the subject to blink, that is, there is an eyelash reflex. When the eyelash reflex disappears, the patient has entered a state of anesthesia
Measured: up to 2 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start9 Nov 2023
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QT Interval, Variation inStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qing Wen, Master, Principal investigator, Jinan Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822153
- Sponsor's protocol ID
- ET-26-HCL-CP-002
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-label, Placebo-controlled Phase I Clinical Trial Was Conducted to Evaluate the Pharmacokinetics and QT Interval Effects of a Single Intravenous Injection of Methoxyethyl Etomidate Hydrochloride in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06822153
- Acronym / sponsor ID
- ET-26-HCL-CP-002
- Conditions
- QT Interval, Variation in
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 12 Feb 2025 (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.
A single intravenous injection of 0.8mg/kg or 2.8mg/kg Et-26-hcl was given to 18 subjects. The effect of plasma concentration on QT interval was evaluated by C-QTc effect model, and the pharmacokinetic characteristics and safety of ET-26 and etomidate acid were evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-dose group | Other | Drug: ET-26 0.8mg/kg(low-dose) groupPlacebo+ET-26 0.8mg/kg |
| High dose group | Other | Drug: ET-26 2.8mg/kg(high dose) groupPlacebo+ET-26 2.8mg/kg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male and female subjects;
- Age: 18-45 years old;
- Body weight: body mass index (BMI) between 19.0 and 28.0 kg/m2, with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
- voluntarily sign informed consent;
- Subjects were able to communicate well with investigators and complete the trial in accordance with the protocol.
Key exclusion criteria (31 listed)
- -
- those with clinically significant abnormalities in comprehensive physical examination, vital signs, and laboratory tests (blood routine, blood biochemistry, coagulation function, urine routine, serum cortisol);
- potentially difficult airway (modified Mallampati score III-IV);
- abnormal and clinically significant hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia as judged by the investigator;
- clinically significant abnormal 12-lead ECG, QTcF≥450 ms, PR interval ≥200 ms, QRS complex duration ≥120ms;
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 |
|---|---|---|
| ET-26 0.8mg/kg(low-dose) groupIn a 2:1 ratio, Placebo was administered with normal saline and ET-26 0.8mg/kg for a duration of 60 ±5 seconds. | Drug | low-dose group |
| ET-26 2.8mg/kg(high dose) groupIn a 2:1 ratio, Placebo was administered with normal saline and ET-26 2.8mg/kg for a duration of 60 ±5 seconds. | Drug | High dose group |
Primary outcome
Pharmacokinetic parameters
Time frame: from 1 hour before administration of et-26 until 24 hours after the end of administration.
Cmax
2 secondary outcomes
MOAA/S
Time frame: up to 10 minutes after drug administration
Eyelash reflex
Time frame: up to 2 minutes after drug administration
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 14 Feb 2025.
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.
Qing Wen, Master principal investigator
Jinan Central Hospital
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 ET-26 0.8mg/kg(low-dose) group and ET-26 2.8mg/kg(high dose) group in people with QT Interval, Variation in, run by Ahon Pharmaceutical 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 5 inclusion and 31 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 14 Feb 2025. 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?
Pharmacokinetic parameters (time frame: from 1 hour before administration of et-26 until 24 hours after the end of administration.). 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 14 Feb 2025.