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

NCT05418348 | Completed Phase 1 FDA Drug

• 1 other identifier: GTX-104-002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Cmax Day 1

  Maximum concentration

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

• AUC (AUCDay 3, 0-24hr)

  Area under the concentration-time curve

  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

  Day 3

• Absolute bioavailability (F) Day 3

  Day 3

• Total body clearance of the drug from plasma after IV infusion (CL) Day 3

  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

  Day 3 from 8:00 AM to 8:00 AM from 0 to 24 h

Study Arms (2)

Treatment A (GTX-104 IV, Test):

EXPERIMENTAL

Nimodipine was administered by infusion over 72 hours.

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.

Drug: Nimodipine Capsules

Interventions

GTX-104 DRUG

new formulation of nimodipine injection for IV infusion

Treatment A (GTX-104 IV, Test):

Nimodipine Capsules DRUG

Nimodipine capsules (reference formulation)

Treatment B (NIMOTOP, RLD):

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grace Therapeutics Inc.: lead

Study Sites (1)

Clinical Research Unit

Montreal, Canada

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Nimodipine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nicotinic Acids

Study Officials

• Eric Sicard, MD

  Clinical Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 14, 2022
• Study Start: August 26, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 24, 2022
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)