NCT05418348

Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects

A Phase 1, Randomized, Two-Period Crossover Study to Evaluate the Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules at Steady State in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Grace Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single center, randomized, two-period crossover study in healthy male and female subjects designed to evaluate the relative bioavailability (BA) and safety at steady state of two formulations of nimodipine: GTX 104 (nimodipine for intravenous \[IV\] infusion; test formulation) and nimodipine oral capsules, RS (reference formulation).

Conditions

• Aneurysmal Subarachnoid Hemorrhage

Interventions

Type	Name	Description
DRUG	GTX-104	new formulation of nimodipine injection for IV infusion
DRUG	Nimodipine Capsules	Nimodipine capsules (reference formulation)

Timeline

• Start date: 2021-08-26
• Primary completion: 2022-02-17
• Completion: 2022-02-24
• First posted: 2022-06-14
• Last updated: 2023-08-31

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study