Aneurysmal Subarachnoid Hemorrhage
Conditions
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).
Interventions
DRUGGTX-104
new formulation of nimodipine injection for IV infusion
Nimodipine capsules (reference formulation)
Sponsors
Grace Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax Day 1 | Day 1 for the first dose (8:00 AM dose) | Maximum concentration |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed