Healthy Chinese Subjects
Conditions
Keywords
Etripamil, Paroxysmal supraventricular tachycardia, Tachycardia, Tachycardia, Supraventricular
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
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.
Interventions
DRUGEtripamil Nasal Spray 70mg
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.
DRUGPlacebo
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.
Sponsors
Milestone Pharmaceuticals Inc.
Corxel Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
JX02001 is a double blind phase 1 study.
Intervention model description
A Single Center, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who meet all the following criteria at screening may be included in the study: 1. Ethnically Chinese men or women, 18 to 45 years of age (inclusive). 2. Body weight: male ≥50 kg, female ≥45 kg; body mass index (BMI) within 18 to 26 kg/m2 (inclusive). 3. Healthy subject as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital signs. 4. 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. 5. Non-smoker or ex-smoker for \>6 months. 6. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of Etripamil after single dosing | Day -1 to Day 11 | To measure Cmax of Etripamil after single dosing |
| Cmax of MSP-2030 after single dosing | Day -1 to Day 11 | To measure Cmax of MSP-2030 after single dosing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concomitant medications that subjects take | Day -1 to Day 11 | To record subject clinical laboratory tests outcomes |
| PR interval after single dosing | Day -1 to Day 11 | To measure PR interval by electrocardiogram after single dosing |
| Subject electrocardiogram outcomes | Day -1 to Day 11 | To record number of participants with abnormal electrocardiogram readings |
| Heart rate after single dosing | Day -1 to Day 11 | To measure heart rate after single dosing |
| Subject incidence of Adverse Event (AE) | Day -1 to Day 11 | To record subject incidence of Adverse Event (AE) |
| Blood pressure after single dosing | Day -1 to Day 11 | To measure systolic and diastolic blood pressure after single dosing |
| Subject clinical laboratory tests outcomes | Day -1 to Day 11 | To record number of participants with abnormal laboratory test results |
Countries
China
Outcome results
None listed