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

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05418348
• Other study ID #: GTX-104-002
• Status: Completed
• Phase: Phase 1
• Start date: August 26, 2021
• Est. completion date: February 24, 2022

Study information

• Verified date: August 2023
• Source: Acasti Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 24, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Subject had a body mass index between 18 and 32 kg/m2, inclusive.

• Subject was in good general physical health as determined by absence of clinically significant (CS) medical or psychiatric history, physical examination findings, vital signs, clinical laboratory evaluations, and 12-lead ECG measurements.

Exclusion Criteria:

• History or presence of clinically significant medical illness, including, but not limited to, cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease, that could have interfered with the interpretation of the study.

• Had current or recent (within 6 months) history of gastrointestinal disease or any surgical or medical condition (eg, Crohn's or liver disease) that could potentially alter the absorption, metabolism, or excretion of the study drug.

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• GTX-104
new formulation of nimodipine injection for IV infusion
• Nimodipine Capsules
Nimodipine capsules (reference formulation)

Locations

Country	Name	City	State
Canada	Clinical Research Unit	Montréal

Sponsors (1)

Lead Sponsor	Collaborator
Acasti Pharma Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax Day 1	Maximum concentration	Day 1 for the first dose (8:00 AM dose)
Primary	AUC (AUCDay 3, 0-24hr)	Area under the concentration-time curve	Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr
Secondary	Cmax Day 3 across all 6 doses	Maximum concentration across all doses	Day 3
Secondary	Absolute bioavailability (F) Day 3	the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Treatment-1 and Treatment-2 for the ln-transformed parameters Cmax Day3	Day 3
Secondary	Total body clearance of the drug from plasma after IV infusion (CL) Day 3	(Dosedaily/AUCDay3,0-24)	Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
Secondary	Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3	Dosedaily/AUCDay 3 0-24	Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h