A Study of Etripamil in Healthy Subjects

NCT05511870 | Completed Phase 1 FDA Drug

• 1 other identifier: JX02001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Chinese Subjects

Keywords

Etripamil; Paroxysmal supraventricular tachycardia; Tachycardia; Tachycardia, Supraventricular

Outcome Measures

Primary Outcomes (2)

• Cmax of Etripamil after single dosing

  To measure Cmax of Etripamil after single dosing

  Day -1 to Day 11

• Cmax of MSP-2030 after single dosing

  To measure Cmax of MSP-2030 after single dosing

  Day -1 to Day 11

Secondary Outcomes (7)

• PR interval after single dosing

  Day -1 to Day 11

• Blood pressure after single dosing

  Day -1 to Day 11

• Heart rate after single dosing

  Day -1 to Day 11

• Subject incidence of Adverse Event (AE)

  Day -1 to Day 11

• Subject electrocardiogram outcomes

  Day -1 to Day 11

Study Arms (2)

Etripamil Nasal Spray 70mg

EXPERIMENTAL

Etripamil Nasal Spray 70mg single dose

Drug: Etripamil Nasal Spray 70mg

Etripamil Placebo Nasal Spray 70mg

PLACEBO COMPARATOR

Etripamil Placebo Nasal Spray 70mg single dose

Drug: Placebo

Interventions

Etripamil Nasal Spray 70mg DRUG

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.

Etripamil Nasal Spray 70mg

Placebo DRUG

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.

Etripamil Placebo Nasal Spray 70mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.
• 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.

Sponsors & Collaborators

• Corxel Pharmaceuticals: lead
• Milestone Pharmaceuticals Inc.: collaborator

Study Sites (1)

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Tachycardia; Tachycardia, Supraventricular

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing ZHANG

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Yuewen XI

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

• Lihang QI

  Corxel Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: JX02001 is a double blind phase 1 study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 23, 2022
• Study Start: March 7, 2023
• Primary Completion: March 26, 2023
• Study Completion: March 26, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-03

Locations

CN (1)