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CompletedNCT05418348Updated Aug 31, 2023

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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).

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Conditions studied

  • Aneurysmal Subarachnoid Hemorrhage
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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts 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

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

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Treatment A (GTX-104 IV, Test):

    Nimodipine was administered by infusion over 72 hours.

    Drug: GTX-104

  • Experimental
    Treatment B (NIMOTOP, RLD):

    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

Interventions

  • DrugGTX-104

    new formulation of nimodipine injection for IV infusion

  • DrugNimodipine Capsules

    Nimodipine capsules (reference formulation)

05

What researchers measure

Primary outcomes

  1. Cmax Day 1

    Maximum concentration

    Time frame: Day 1 for the first dose (8:00 AM dose)

  2. 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

Secondary outcomes

  1. Cmax Day 3 across all 6 doses

    Maximum concentration across all doses

    Time frame: Day 3

  2. 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

  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

  4. 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

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Study locations

1 site
  • Clinical Research Unit
    Montréal, Canada
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05418348
Lead sponsor
Grace Therapeutics Inc.
Responsible party
Sponsor
First posted
Jun 14, 2022
Start date
Aug 26, 2021
Primary completion
Feb 17, 2022
Completion
Feb 24, 2022
Last update
Aug 31, 2023

Study contacts

Eric Sicard, MD
principal investigator · Clinical Research Unit

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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