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NCT Number: NCT05418348

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

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Research Unit

Montreal, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GTX-104

Drug

new formulation of nimodipine injection for IV infusion

Nimodipine Capsules

Drug

Nimodipine capsules (reference formulation)

Primary outcomes

  1. Cmax Day 1

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

    Maximum concentration

  2. 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

Secondary outcomes

  1. Cmax Day 3 across all 6 doses

    Time frame: Day 3

    Maximum concentration across all doses

  2. Absolute bioavailability (F) Day 3

    Time frame: 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

  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

    (Dosedaily/AUCDay3,0-24)

  4. 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

    Dosedaily/AUCDay 3 0-24

Sponsors and collaborators

Lead sponsor

Grace Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 14, 2022
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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