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

Phase 1

Completed

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Drug: Nimodipine Capsules; Drug: GTX-104

• Registration Number: NCT05418348
• Lead Sponsor: Acasti Pharma Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-26
• Primary Completion: 2022-02-17
• Study Completion: 2022-02-24
• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-14
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B (NIMOTOP, RLD):	Nimodipine Capsules	Nimodipine capsules (RS) administered orally with 240 mL of water at a dose level of 60 mg (two 30 mg capsules) q4h for 72 hours.
Treatment A (GTX-104 IV, Test):	GTX-104	Nimodipine was administered by infusion over 72 hours.

Primary Outcome Measures

Name	Time	Method
AUC (AUCDay 3, 0-24hr)	Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr	Area under the concentration-time curve
Cmax Day 1	Day 1 for the first dose (8:00 AM dose)	Maximum concentration

Secondary Outcome Measures

Name	Time	Method
Cmax Day 3 across all 6 doses	Day 3	Maximum concentration across all doses
Absolute bioavailability (F) Day 3	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
Total body clearance of the drug from plasma after IV infusion (CL) Day 3	Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h	(Dosedaily/AUCDay3,0-24)
Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3	Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h	Dosedaily/AUCDay 3 0-24

Trial Locations

Locations (1)

Clinical Research Unit; 🇨🇦 Montréal, Canada