NCT05511870

A Study of Etripamil in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Corxel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Chinese Subjects

Interventions

Type	Name	Description
DRUG	Etripamil 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.
DRUG	Placebo	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.

Timeline

• Start date: 2023-03-07
• Primary completion: 2023-03-26
• Completion: 2023-03-26
• First posted: 2022-08-23
• Last updated: 2023-04-10

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study