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

NCT ID: NCT05418348

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-26
• Study Completion Date: 2022-02-24

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).

Conditions

Aneurysmal Subarachnoid Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment A (GTX-104 IV, Test):

Nimodipine was administered by infusion over 72 hours.

Group Type: EXPERIMENTAL

GTX-104

Intervention Type: DRUG

new formulation of nimodipine injection for IV infusion

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.

Group Type: EXPERIMENTAL

Nimodipine Capsules

Intervention Type: DRUG

Nimodipine capsules (reference formulation)

Interventions

GTX-104

new formulation of nimodipine injection for IV infusion

Intervention Type: DRUG

Nimodipine Capsules

Nimodipine capsules (reference formulation)

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Grace Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Sicard, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Unit

Locations

Clinical Research Unit

Montreal, , Canada

Countries

Canada

Other Identifiers

GTX-104-002

Identifier Type: -

Identifier Source: org_study_id