A Phase 1 interventional study of GTX-104 and Nimodipine Capsules in Aneurysmal Subarachnoid Hemorrhage, sponsored by Grace Therapeutics Inc.. Completed at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-31.
Sponsored by Grace Therapeutics Inc. · Phase 1, Interventional, and Treatment
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Among 27 studies in Subarachnoid Hemorrhage with a site in Canada — 4 open to participants now, 5 under way, none of them phase 3. Subarachnoid Hemorrhage · Canada.
Among the 27 studies in Subarachnoid Hemorrhage with a site in Canada, this one is the 14th largest by enrollment of the 23 interventional ones that give a count, is one of 4 that started in 2021, is one of 3 in phase 1, and was the 24th registered.
510 studies on the registry are indexed under Subarachnoid Hemorrhage; 128 are open to participants now.
Browse Subarachnoid Hemorrhage studies →4 of the 27 studies in Subarachnoid Hemorrhage with a site in Canada are open now. Recruiting first, the newest first:
Columbia University · Sites in Canada, United States, Brazil and 2 more countries
Ages 18+
University of Alberta · Sites in Canada, United States
Ages 18–85
University of Alberta · Sites in Canada, United States
Ages 18–85
CHU de Quebec-Universite Laval · Sites in Canada
Ages 18+
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 89 Subarachnoid Hemorrhage studies recruiting now, 56 (63%) set no upper age limit and 4 (4%) stop at 75 or younger; 7 take children under 18; 7 take healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
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27 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 8 · Phase 3 6 · Phase 4 2
First in 2000; this study’s year is marked. 4 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 58 is close to the median of 57 across 264 interventional studies indexed under Subarachnoid Hemorrhage.
Median enrollment 73 across the 23 interventional studies, 393 across the 4 observational. Of the 16 that completed or were terminated, 5 (31%) have results posted.
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11 of 27 have an industry lead sponsor. The 10 most frequent:
Grace Therapeutics Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Grace Therapeutics Inc. has 2 studies filed under Subarachnoid Hemorrhage — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 27 studies in Subarachnoid Hemorrhage with a site in Canada, from their registry updates:
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nimodipine was administered by infusion over 72 hours.
Drug: GTX-104
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.
Drug: Nimodipine Capsules
new formulation of nimodipine injection for IV infusion
Nimodipine capsules (reference formulation)
Cmax Day 1
Maximum concentration
Time frame: Day 1 for the first dose (8:00 AM dose)
AUC (AUCDay 3, 0-24hr)
Area under the concentration-time curve
Time frame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr
Cmax Day 3 across all 6 doses
Maximum concentration across all doses
Time frame: Day 3
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
Time frame: Day 3
Total body clearance of the drug from plasma after IV infusion (CL) Day 3
(Dosedaily/AUCDay3,0-24)
Time frame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
Apparent total body clearance of the drug from plasma after oral administration (CL/F) Day 3
Dosedaily/AUCDay 3 0-24
Time frame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in Feb 2022, 5 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nimodipine
Grace Therapeutics Inc.