Aneurysmal Subarachnoid HemorrhagePhase 1NCT05418348
Relative Bioavailability of Intravenous GTX-104 Compared to Oral Nimodipine Capsules in Healthy Subjects
A Phase 1 study testing GTX-104 and Nimodipine Capsules in people with Aneurysmal Subarachnoid Hemorrhage, run by Grace Therapeutics Inc. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- GTX-104 and Nimodipine Capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2021to 24 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- GTX-104, Nimodipine Capsules
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTX-104Drug
new formulation of nimodipine injection for IV infusion
Nimodipine CapsulesDrug
Nimodipine capsules (reference formulation)
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (GTX-104 IV, Test): | Experimental | Nimodipine was administered by infusion over 72 hours. Receives: Drug: GTX-104 |
| Treatment B (NIMOTOP, RLD): | Experimental | 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. Receives: Drug: Nimodipine Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax Day 1
Maximum concentration
Measured: Day 1 for the first dose (8:00 AM dose)
AUC (AUCDay 3, 0-24hr)
Area under the concentration-time curve
Measured: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr
Secondary outcomes (4)
Cmax Day 3 across all 6 doses
Maximum concentration across all doses
Measured: 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
Measured: Day 3
Total body clearance of the drug from plasma after IV infusion (CL) Day 3
(Dosedaily/AUCDay3,0-24)
Measured: 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
Measured: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start26 Aug 2021
- Primary completion17 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, MD, Principal investigator, Clinical Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418348
- Sponsor's protocol ID
- GTX-104-002
- Status last verified
- Aug 2023
- First submitted
- 10 Jun 2022
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05418348
- Acronym / sponsor ID
- GTX-104-002
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Grace Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (GTX-104 IV, Test): | Experimental | Drug: GTX-104Nimodipine was administered by infusion over 72 hours. |
| Treatment B (NIMOTOP, RLD): | Experimental | Drug: Nimodipine CapsulesNimodipine capsules (RS) administered orally with 240 mL of water at a dose level of 60 mg (two 30 mg capsules) q4h for 72 hours. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTX-104new formulation of nimodipine injection for IV infusion | Drug | Treatment A (GTX-104 IV, Test): |
| Nimodipine CapsulesNimodipine capsules (reference formulation) | Drug | Treatment B (NIMOTOP, RLD): |
Primary outcome
Cmax Day 1
Time frame: Day 1 for the first dose (8:00 AM dose)
Maximum concentration
AUC (AUCDay 3, 0-24hr)
Time frame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 hr
Area under the concentration-time curve
4 secondary outcomes
Cmax Day 3 across all 6 doses
Time frame: Day 3
Absolute bioavailability (F) Day 3
Time frame: Day 3
Total body clearance of the drug from plasma after IV infusion (CL) Day 3
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
Time frame: Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Aneurysmal Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sicard, MD principal investigator
Clinical Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GTX-104 and Nimodipine Capsules in people with Aneurysmal Subarachnoid Hemorrhage, run by Grace Therapeutics Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax Day 1 (time frame: Day 1 for the first dose (8:00 AM dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.