drugset
drugset / Trial / 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

NCT03099824 ↗

Phase 1 Completed 56 enrolled Galera Therapeutics, Inc.
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2018-10-16
Primary completion
2020-01-27
Completion
2020-01-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Avasopasem manganese Other / unclassified 27 mg Intravenous
Subject RUCOSOPASEM MANGANESE Other / unclassified 30 mg Oral
Subject RUCOSOPASEM MANGANESE Other / unclassified 82 mg Oral
Subject RUCOSOPASEM MANGANESE Other / unclassified 145 mg Oral
Subject RUCOSOPASEM MANGANESE Other / unclassified 164 mg Oral
Subject RUCOSOPASEM MANGANESE Other / unclassified 175 mg Oral
Subject RUCOSOPASEM MANGANESE Other / unclassified 233 mg Oral
Subject RUCOSOPASEM MANGANESE Other / unclassified 246 mg Oral

Indications

No indication recorded.