NCT07445464

An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers

A Phase 1, Randomized, Open-Label, Single-Dose, Five-Way Crossover Study to Compare the Pharmacokinetics of Asp-001, 2 Mg And 5 Mg Orally Disintegrating Tablets (Formulations A And B) With Sibelium® 5 Mg Tablet in Healthy Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Aspartes Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study will assess the pharmacokinetics (PKs), safety and tolerability of ASP-001 in healthy volunteers. ASP-001 is an orally disintegrating tablet (ODT) formulation of flunarizine. This study will assess two formulations, Formulation A and Formulation B, at dose levels of 2 and 5 mg compared to the reference product, the Sibelium brand of flunarizine 5 mg tablet. Whilst this is not a first-in-human (FIH) study of flunarizine, which is available in countries outside of Australia and has been studied extensively, it is a FIH study of ASP-001. In this open-label study, 12 participants will be assigned to one of five dosing sequences, in which they will receive a single dose of ASP-001 or Sibelium 5 mg in five separate dosing periods. The study drugs will be: * Treatment A: ASP-001 Formulation A, 5 mg * Treatment B: ASP-001 Formulation A, 2 mg * Treatment C: ASP-001 Formulation B, 5 mg * Treatment D: ASP-001 Formulation B, 2 mg * Treatment E: Sibelium, 5 mg Each dosing period will be separated by at least a 7-day washout period after the day of dosing. Approximately 14 days after the fifth and final dosing day, participants will return to the site to complete their end of study assessments. Aboriginal and Torres Strait Islander participants will not be targeted directly; however, they will be permitted to be on-study if they meet all of the eligibility criteria. Participants under the age of 18 will not be permitted on study.

Conditions

• Pharmacokinetic Analysis

Interventions

Type	Name	Description
DRUG	Flunarizine	ODT formulation for buccal administration
DRUG	Flunarizine	oral tablet

Timeline

• Start date: 2026-04-09
• Primary completion: 2026-06-02
• Completion: 2026-07-01
• First posted: 2026-03-03
• Last updated: 2026-03-03