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Healthy Chinese SubjectsPhase 1NCT05511870

A Study of Etripamil in Healthy Subjects

A Phase 1 study testing Etripamil Nasal Spray 70mg in people with Healthy Chinese Subjects, run by Corxel Pharmaceuticals at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objectives of the study are as below: Primary: ·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects Secondary: To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese subjects To evaluate the safety and tolerability of Etripamil in healthy adult Chinese 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 Chinese Subjects
What is being tested?
Etripamil Nasal Spray 70mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteChina
Study dates
7 Mar 2023to 26 Mar 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

  • Subjects who meet all the following criteria at screening may be included in the study:
  • Ethnically Chinese men or women, 18 to 45 years of age (inclusive).
  • Body weight: male ≥50 kg, female ≥45 kg; body mass index (BMI) within 18 to 26 kg/m2 (inclusive).
  • Healthy subject as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs.
  • Able to comprehend and willing to sign the ICF which includes compliance with the inclusion and exclusion criteria listed in the ICF and in the protocol.
  • Non-smoker or ex-smoker for >6 months.
  • From the time they sign the informed consent to 90 days (male subject within 30 days) after dosing, subjects have no plans to have children and voluntarily use effective contraception

Who cannot join

  • Any of the following will exclude subjects from the study:
  • Have a history of, or current clinically significant medical illness including but not limited to, cardiac arrhythmias or other cardiac disease; hematologic disease; coagulation disorders (including any abnormal bleeding or blood dyscrasias); significant pulmonary disease, including bronchospastic respiratory disease; diabetes mellitus; hepatic or renal disease; thyroid disease; neurologic or psychiatric disease; or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.
  • A history of atrioventricular (AV) block, (1st, 2nd or 3rd degree), myocardial infarction (MI) or angina, non-sustained or sustained ventricular tachycardia (VT), torsade de pointes, family history of sudden death or prolonged QT interval, vaso-vagal syncope, sick sinus syndrome, supraventricular tachycardia, atrial flutter, atrial fibrillation (AFib), stroke, transient ischemic attack (TIA), unexplained syncope, congestive heart failure (CHF).
  • Acute upper respiratory tract infection within 14 days prior to dosing.
  • Any abnormality of the nasal passage.
  • Unable to tolerate IN administration.
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  • Known sensitivity to verapamil or other drugs or foods.
  • Clinically significant abnormal values for clinical laboratory tests at screening as deemed appropriate by the investigator.
  • Serum potassium <3.5mmol/L or serum magnesium <0.75mmol/L or serum calcium <2.11mmol/L.
  • Systolic blood pressure (SBP) <100 or >140 mmHg, diastolic blood pressure (DBP) <55 or >90 mmHg, HR <65 or >95 bpm.
  • QTcF >440 msec, flat or biphasic T waves, QRS >105 ms, evidence of a prior MI, pathologic U waves or U waves that interfere with the QT measurement, AV block or left anterior hemiblock (LAHB) or left posterior hemiblock (LPHB) or right bundle branch block (RBBB) or left bundle branch block (LBBB), pre-excitation syndrome.
  • Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening as deemed appropriate by the Investigator.
  • Have a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV; have a history of treponema pallidum antibody positive, or tests positive for treponema pallidum; have a history of hepatitis B virus surface antigen (HBsAg) or hepatitis C virus antibody (HCVAb) positive, or other clinically active liver disease, or tested positive for HBsAg or HCVAb at screening.
  • History of drug or alcohol abuse in the last 2 years..
  • Positive test result(s) for alcohol and/or drugs of abuse at screening or admission (Day-1).
  • Received an investigational drug or used an invasive investigational medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before dosing.
  • Use of any prescription or non-prescription medication within 14 days or 5 half-lives (whichever is longer), or complementary and alternative medicine within 28 days before dosing (excluding aspirin, ibuprofen, and acetaminophen).
  • Any blood donation within 60 days prior to dosing, or any plasma donation within 30 days prior to dosing, or receipt of blood products within 60 days prior to dosing.
  • Vaccinated within 30 days prior to dosing or planned to be vaccinated during this study.
  • Have preplanned surgery or procedures that will interfere with the conduct of the study.
  • Sponsor staff and/or staff at the study site.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Etripamil in Healthy Chinese Subjects

The objectives of the study are as below:

Primary:

·To evaluate the pharmacokinetics (PK) of Etripamil in healthy adult Chinese subjects

Secondary:

  • To evaluate the pharmacodynamics (PD) of Etripamil in healthy adult Chinese subjects
  • To evaluate the safety and tolerability of Etripamil in healthy adult Chinese subjects

Exploratory:

·To evaluate the PK exposure-PD response relationship of etripamil in healthy adult Chinese subjects

Read the detailed description

This is a randomized, double-blind, placebo-controlled phase 1 study in healthy adult Chinese subjects to evaluate the PK, PD, safety and tolerability of single dose of etripamil, 70 mg nasal spray (NS). After signing the informed consent form (ICF), potential subjects will undergo screening procedures within 28 days prior to dosing. Eligible subjects will be admitted to the clinical unit on Day -1 and screening procedures will be repeated to confirm eligibility. Subjects will fast overnight for at least 10 hours prior to dosing. 12 healthy adult Chinese subjects will be randomized to receive etripamil 70 mg single dose (n=10) or placebo (n=2).

Blood and urine samples will be collected for PK assessments of etripamil and the inactive main metabolite MSP-2030.

AEs, 12-lead ECGs, clinical laboratory tests, vital signs, physical examinations, and concomitant medications will be collected and evaluated over the course of study.

Subjects will remain in clinic until discharged on Day 2. There will be a follow-up telephone call on Day 11 (±1 day) of dosing. Total duration for each subject will be approximately 1.5 months.

Being tested
Etripamil Nasal Spray 70mg, Placebo
Keywords
Etripamil, Paroxysmal supraventricular tachycardia, Tachycardia, Tachycardia, Supraventricular
Medical subject headings
Tachycardia, Ventricular, Tachycardia, Tachycardia, Supraventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Etripamil Nasal Spray 70mgDrug

    Etripamil NS 70 mg will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

  • PlaceboDrug

    Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.

Study groups in NCT05511870
Study groupRoleWhat they receive
Etripamil Nasal Spray 70mgExperimentalEtripamil Nasal Spray 70mg single dose
Receives: Drug: Etripamil Nasal Spray 70mg
Etripamil Placebo Nasal Spray 70mgPlacebo comparatorEtripamil Placebo Nasal Spray 70mg single dose
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of Etripamil after single dosing

    To measure Cmax of Etripamil after single dosing

    Measured: Day -1 to Day 11

  2. Cmax of MSP-2030 after single dosing

    To measure Cmax of MSP-2030 after single dosing

    Measured: Day -1 to Day 11

Secondary outcomes (7)

  1. PR interval after single dosing

    To measure PR interval by electrocardiogram after single dosing

    Measured: Day -1 to Day 11

  2. Blood pressure after single dosing

    To measure systolic and diastolic blood pressure after single dosing

    Measured: Day -1 to Day 11

  3. Heart rate after single dosing

    To measure heart rate after single dosing

    Measured: Day -1 to Day 11

  4. Subject incidence of Adverse Event (AE)

    To record subject incidence of Adverse Event (AE)

    Measured: Day -1 to Day 11

  5. Subject electrocardiogram outcomes

    To record number of participants with abnormal electrocardiogram readings

    Measured: Day -1 to Day 11

  6. Subject clinical laboratory tests outcomes

    To record number of participants with abnormal laboratory test results

    Measured: Day -1 to Day 11

  7. Concomitant medications that subjects take

    To record subject clinical laboratory tests outcomes

    Measured: Day -1 to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2022
  2. Study start7 Mar 2023
  3. Primary completion26 Mar 2023
  4. Study completion26 Mar 2023

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05511870
Sponsor's protocol ID
JX02001
Status last verified
Mar 2023
First submitted
7 Aug 2022
Last updated
10 Apr 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Etripamil Nasal Spray 70mg in people with Healthy Chinese Subjects, run by Corxel Pharmaceuticals 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 7 inclusion and 21 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 10 Apr 2023. 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. Some participants in this study may receive a placebo. 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?

Cmax of Etripamil after single dosing (time frame: Day -1 to Day 11). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05511870.

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 10 Apr 2023.

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