Renal InsufficiencyPhase 1NCT06747520
Phase 1 Renal Insufficiency Trial of Methoxyethyl Etomidate Hydrochloride
A Phase 1 study testing ET-26HCl in people with Renal Insufficiency, run by Ahon Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Twenty-four subjects were divided into three groups: subjects with mild renal insufficiency, subjects with moderate renal insufficiency and subjects with normal renal function, with 8 subjects in each group.Subjects with mild renal insufficiency and moderate renal insufficiency were enrolled first, and then subjects… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- ET-26HCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2023to 28 Feb 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects
- adult male and female subjects aged ≥18 years;
- Body weight: body mass index (BMI) between 18.0 and 30.0 kg/m2 (including the cut-off value), with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
- The subjects had good communication with the investigators, voluntarily signed the informed consent form and were able to complete the trial in accordance with the protocol; Subjects with renal insufficiency
- The glomerular filtration rate (GFR) should meet the following criteria: mild renal insufficiency 60-89 mL/min (including both ends), moderate renal insufficiency subjects 30-59 mL/min (including both ends);
- stable renal function with two absolute eGFR results (separated by at least 3 days) within the same CKD stage before administration;
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- no medication within 14 days before screening or with a stable medication regimen for renal impairment or other comorbidities (no adjustment in medication type, dose, or frequency for at least 2 weeks);
- In addition to renal insufficiency and complications, the investigator judged the recipient's physical status according to medical history inquiry, physical examination, vital signs, cortisol test, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), and 12-lead electrocardiogram.
- Subjects with normal renal function 8) matched with the renal insufficiency group by age (±10 years), weight (±15 kg), and gender (1:1); 9) GFR ≥90 mL/min; 10) normal or abnormal results of physical examination, vital signs, cortisol test, laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), and 12-lead electrocardiogram without clinical significance.
Who cannot join
- All subjects
- potentially difficult airway (modified Mallampati score III-IV);
- hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 14 days before screening;
- a history of severe cardiovascular disease, including but not limited to organic heart disease, such as heart failure, myocardial infarction, angina pectoris, and malignant arrhythmia; 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);
- patients with severe infection, trauma, major surgery, or digestive system surgery within 1 month before screening that affect drug absorption;
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- those with allergic constitution, such as those with a known history of allergic to two or more substances; Or who, as judged by the investigator, may be allergic to the trial drug or its excipients;
- binge drinking or regular drinking in the 6 months before screening, defined as 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 at baseline;
- smokers with an average of more than 5 cigarettes per day in the 3 months before screening or unable to quit smoking during the study;
- those with drug abuse or drug use history within 3 months before screening; Or the baseline urine drug test was positive;
- habitual consumption of grapefruit juice or excessive tea, coffee and/or caffeinated beverages and inability to quit during the trial;
- those who have difficulty in blood collection or cannot tolerate blood collection by venipuncture;
- participated in any other clinical trials (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;
- those who plan to give birth or donate sperm during the trial and 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 half a year after the completion of the trial;
- had blood loss or donation > 400 mL within 3 months before screening, or received blood transfusion within 1 month;
- subjects with any factors considered by the investigator to be ineligible for the trial.
- Subjects with renal insufficiency
- received a kidney transplant;
- required renal dialysis during the study period;
- urinary incontinence or anuria;
- patients with acute disease of any organ other than the disease causing the diagnosis of renal insufficiency, and patients with any chronic disease (e.g., hepatic insufficiency) that could affect the internal course of the study drug were judged by the investigator to be ineligible for the trial;
- abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT>15×ULN), or clinically significant bleeding symptoms or clear bleeding tendency within 3 months before screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or receiving thrombolytic and anticoagulant therapy;
- systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg at screening; The pulse was >100 bpm.
- Subjects with normal renal function
- have a history of any clinically serious illness or disease or condition that the investigator considers may affect the trial results, including but not limited to a history of circulatory, respiratory, endocrine, nervous, digestive, urinary, or hematologic, immunologic, psychiatric, or metabolic diseases;
- systolic blood pressure <90 mmHg or >139 mmHg, diastolic blood pressure <60 mmHg or >89 mmHg, and pulse <55 bpm or >100 bpm at screening;
- have taken any prescribed medication within 14 days before dosing;
- use of over-the-counter medicines, Chinese herbal medicines, or food supplements such as vitamins, calcium supplements within 7 days before administration;
- cannot tolerate arterial blood sampling (e.g., Allen's test positive).
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
Jinan, Shandong, 250014
About this study
Official title: A Phase I Clinical Trial Assessing the Safety and Pharmacokinetics of a Single Intravenous Administration of Methoxetamine Hydrochloride in Subjects With Mild to Moderate Renal Impairment Compared to Individuals With Normal Renal Function
Twenty-four subjects were divided into three groups: subjects with mild renal insufficiency, subjects with moderate renal insufficiency and subjects with normal renal function, with 8 subjects in each group.Subjects with mild renal insufficiency and moderate renal insufficiency were enrolled first, and then subjects with normal renal function were matched according to age, weight and gender. All patients received a single intravenous injection of 0.8mg/kg ET-26. To compare the pharmacokinetic characteristics of ET-26 and etomidate acid in subjects with mild and moderate renal insufficiency and normal renal function, and to provide clinical guidance for the use of ET-26 in patients with mild and moderate renal insufficiency.
- Conditions
- Renal Insufficiency
- Being tested
- ET-26HCl
- Keywords
- Clinical Pharmacology, renal insufficiency
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ET-26HClDrug
The dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s.
| Study group | Role | What they receive |
|---|---|---|
| mild renal insufficiency（group A） | Experimental | 0.8mg/kg group Receives: Drug: ET-26HCl |
| moderate renal insufficiency（group B） | Experimental | 0.8mg/kg group Receives: Drug: ET-26HCl |
| normal renal function（group C） | Experimental | 0.8mg/kg group Receives: Drug: ET-26HCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters
Cmax
Measured: up to 24 hours after infusion
Pharmacokinetic parameters
AUC0-t
Measured: immediately after infusion to 24 hours after infusion
Pharmacokinetic parameters
t1/2
Measured: up to 6 hours after infusion
Secondary outcomes (2)
Pharmacodynamic indicators
Modified Observer"s Assessment of Alertness/Sedation（MOAA/S score）.The minimum score is 0 and the maximum is 5, with a score of 5 indicating that the subject is awake.The score was assessed multiple times throughout the procedure.
Measured: MOAA/S score was measured three times within 60 minutes before administration as baseline value, was performed every 1 minute±5seconds for 5minutes after administration and every 2minutes±30seconds for 5minutes after administration
Pharmacodynamic indicators
Bispectral index(BIS score).The minimum score is 0 and the maximum is 100.The normal range of BIS scores is usually between 90 and 100, with higher values indicating greater brain activity and awareness.The score was assessed multiple times throughout the procedure.
Measured: BIS score was measured three times within 60 minutes before administration as baseline value,was performed every 1 minute±5seconds within 5minutes after administration, and every 2minutes±30seconds after 5minutes, until MOAA/S score ≥5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start30 Nov 2023
- Primary completion21 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Zhao, Pharmaciae Doctor, Study director, The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747520
- Sponsor's protocol ID
- ET-26-HCL-CP-004
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 27 Dec 2024
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Assessing the Safety and Pharmacokinetics of a Single Intravenous Administration of Methoxetamine Hydrochloride in Subjects With Mild to Moderate Renal Impairment Compared to Individuals With Normal Renal Function
- ClinicalTrials.gov ID
- NCT06747520
- Acronym / sponsor ID
- ET-26-HCL-CP-004
- Conditions
- Renal Insufficiency
- Keywords
- Clinical Pharmacology, renal insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ahon Pharmaceutical Co., Ltd.University, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 24 Dec 2024 (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.
Twenty-four subjects were divided into three groups: subjects with mild renal insufficiency, subjects with moderate renal insufficiency and subjects with normal renal function, with 8 subjects in each group.Subjects with mild renal insufficiency and moderate renal insufficiency were enrolled first, and then subjects with normal renal function were matched according to age, weight and gender. All patients received a single intravenous injection of 0.8mg/kg ET-26. To compare the pharmacokinetic characteristics of ET-26 and etomidate acid in subjects with mild and moderate renal insufficiency and normal renal function, and to provide clinical guidance for the use of ET-26 in patients with mild and moderate renal insufficiency.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild renal insufficiency（group A） | Experimental | Drug: ET-26HCl0.8mg/kg group |
| moderate renal insufficiency（group B） | Experimental | Drug: ET-26HCl0.8mg/kg group |
| normal renal function（group C） | Experimental | Drug: ET-26HCl0.8mg/kg group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All subjects
- adult male and female subjects aged ≥18 years;
- Body weight: body mass index (BMI) between 18.0 and 30.0 kg/m2 (including the cut-off value), with a body weight of at least 50 kg for male subjects and 45 kg for female subjects;
- The subjects had good communication with the investigators, voluntarily signed the informed consent form and were able to complete the trial in accordance with the protocol; Subjects with renal insufficiency
- The glomerular filtration rate (GFR) should meet the following criteria: mild renal insufficiency 60-89 mL/min (including both ends), moderate renal insufficiency subjects 30-59 mL/min (including both ends);
Key exclusion criteria (31 listed)
- All subjects
- potentially difficult airway (modified Mallampati score III-IV);
- hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody positive;
- use of any drugs that inhibit or induce hepatic drug-metabolizing enzymes within 14 days before screening;
- a history of severe cardiovascular disease, including but not limited to organic heart disease, such as heart failure, myocardial infarction, angina pectoris, and malignant arrhythmia; 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);
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-26HClThe dose is 0.8 mg/kg, single dose, Infusion time was 60s ± 5s. | Drug | mild renal insufficiency（group A）, moderate renal insufficiency（group B）, normal renal function（group C） |
Primary outcome
Pharmacokinetic parameters
Time frame: up to 24 hours after infusion
Cmax
Pharmacokinetic parameters
Time frame: immediately after infusion to 24 hours after infusion
AUC0-t
Pharmacokinetic parameters
Time frame: up to 6 hours after infusion
t1/2
2 secondary outcomes
Pharmacodynamic indicators
Time frame: MOAA/S score was measured three times within 60 minutes before administration as baseline value, was performed every 1 minute±5seconds for 5minutes after administration and every 2minutes±30seconds for 5minutes after administration
Pharmacodynamic indicators
Time frame: BIS score was measured three times within 60 minutes before administration as baseline value,was performed every 1 minute±5seconds within 5minutes after administration, and every 2minutes±30seconds after 5minutes, until MOAA/S score ≥5
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 27 Dec 2024.
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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.
Wei Zhao, Pharmaciae Doctor study director
The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital of Shandong Province)
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-26HCl in people with Renal Insufficiency, 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 9 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 27 Dec 2024. 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: up to 24 hours after infusion). The study lists 3 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 27 Dec 2024.