NCT03099824

A Phase 1 Study of the Safety and Pharmacokinetics of GC4711 (Oral Capsule) Compared to GC4419 (IV Infusion) and GC4711 (IV Infusion) in Healthy Volunteers

A Phase 1, Open-label Study to Compare the Safety and Pharmacokinetics of Various Formulations of Orally Administered Superoxide Dismutase Mimetic GC4711 With Intravenously Administered Superoxide Dismutase Mimetic GC4419 or GC4711 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Galera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of the phase 1, GTO-003 clinical study is to determine the safety and pharmacokinetics of a single dose of a new drug called GC4711 when given as an oral capsule. This study will compare capsules of GC4711 when given orally to a similar drug, GC4419, or GC4711 when either is given as an intravenous infusion.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GC4711 Oral Capsule G-101	82 mg (1 capsule)
DRUG	IV GC4419	GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.
DRUG	GC4711 Oral Capsule G-101	164 mg (2 capsules)
DRUG	GC4711 Oral Capsule G-101	246 mg (3 capsules)
DRUG	GC4711 Oral Capsule G-111	175 mg (1 capsule)
DRUG	GC4711 Oral Capsule G-112	145 mg (1 capsule)
DRUG	GC4711 Oral Capsule G-119	233 mg (1 capsule)
DRUG	GC4711 Oral Capsule G-125	233 mg (1 capsule)
DRUG	IV GC4711	GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump.

Timeline

• Start date: 2018-10-16
• Primary completion: 2020-01-27
• Completion: 2020-01-27
• First posted: 2017-04-04
• Last updated: 2021-03-02

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study