Back to resultsRelative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects
Primary Purpose
Aneurysmal Subarachnoid Hemorrhage
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
GTX-104
Nimodipine Capsules
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage
Eligibility Criteria
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.
Sites / Locations
- Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment A (GTX-104 IV, Test):
Treatment B (NIMOTOP, RLD):
Arm Description
Nimodipine was administered by infusion over 72 hours.
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.
Outcomes
Primary Outcome Measures
Cmax Day 1
Maximum concentration
AUC (AUCDay 3, 0-24hr)
Area under the concentration-time curve
Secondary Outcome Measures
Cmax Day 3 across all 6 doses
Maximum concentration across all doses
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
Total body clearance of the drug from plasma after IV infusion (CL) Day 3
(Dosedaily/AUCDay3,0-24)
Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3
Dosedaily/AUCDay 3 0-24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05418348
Brief Title
Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
February 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acasti Pharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A (GTX-104 IV, Test):
Arm Type
Experimental
Arm Description
Nimodipine was administered by infusion over 72 hours.
Arm Title
Treatment B (NIMOTOP, RLD):
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
GTX-104
Intervention Description
new formulation of nimodipine injection for IV infusion
Intervention Type
Drug
Intervention Name(s)
Nimodipine Capsules
Intervention Description
Nimodipine capsules (reference formulation)
Primary Outcome Measure Information:
Title
Cmax Day 1
Description
Maximum concentration
Time Frame
Day 1 for the first dose (8:00 AM dose)
Title
AUC (AUCDay 3, 0-24hr)
Description
Area under the concentration-time curve
Time Frame
Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr
Secondary Outcome Measure Information:
Title
Cmax Day 3 across all 6 doses
Description
Maximum concentration across all doses
Time Frame
Day 3
Title
Absolute bioavailability (F) Day 3
Description
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
Time Frame
Day 3
Title
Total body clearance of the drug from plasma after IV infusion (CL) Day 3
Description
(Dosedaily/AUCDay3,0-24)
Time Frame
Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
Title
Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3
Description
Dosedaily/AUCDay 3 0-24
Time Frame
Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Sicard, MD
Organizational Affiliation
Clinical Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Unit
City
Montréal
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects
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