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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
12
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.
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.
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Cmax of Etripamil after single dosing
To measure Cmax of Etripamil after single dosing
Time frame: Day -1 to Day 11
Cmax of MSP-2030 after single dosing
To measure Cmax of MSP-2030 after single dosing
Time frame: Day -1 to Day 11
PR interval after single dosing
To measure PR interval by electrocardiogram after single dosing
Time frame: Day -1 to Day 11
Blood pressure after single dosing
To measure systolic and diastolic blood pressure after single dosing
Time frame: Day -1 to Day 11
Heart rate after single dosing
To measure heart rate after single dosing
Time frame: Day -1 to Day 11
Subject incidence of Adverse Event (AE)
To record subject incidence of Adverse Event (AE)
Time frame: Day -1 to Day 11
Subject electrocardiogram outcomes
To record number of participants with abnormal electrocardiogram readings
Time frame: Day -1 to Day 11
Subject clinical laboratory tests outcomes
To record number of participants with abnormal laboratory test results
Time frame: Day -1 to Day 11
Concomitant medications that subjects take
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To record subject clinical laboratory tests outcomes
Time frame: Day -1 to Day 11