Relative Bioavailability Study of HNC364 Injectable Suspension
At a glance
Conditions
NCT06798519
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Frontage Clinical Services, Inc.
Secaucus, New Jerseyno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Area under the concentration-time curve (AUC) from time 0 to dose interval (AUCτ)Day 1 to 56 days post dose
The relative bioavailability of HNC364 injectable suspension and rasagiline tablets at the steady-state will be calculated by comparing the following PK parameters of rasagiline in both formulations. Due to the negligible plasma concentrations of HNC364 observed following intramuscular injection, the relative bioavailability calculations will be based on the assumption of complete conversion of HNC364 to rasagiline in vivo. To facilitate this comparison, the administered dose of HNC364 (60 mg) will be converted to an equivalent dose of rasagiline based on their respective molecular weights: 60 mg \* 171.24 / 624.91 = 16.44 mg.
- Number of Participants With Treatment Emergent Adverse EventsDay 1 to 56 days post dose
The following assessments will be used to evaluate the safety of HNC364 and rasagiline: monitoring and assessment of adverse events (AEs) and concomitant medications; 12-lead electrocardiograms (ECGs); vital sign measurements (including blood pressure, heart rate, respiratory rate, and oral temperature); clinical laboratory test results (including serum chemistry, hematology, coagulation, and urinalysis); physical examinations and injection site reactions.