A Study of the Safety, Tolerability and Pharmacokinetics of Orally-administered GC4702 in Healthy Volunteers

Phase 1 Completed 48 enrolled Galera Therapeutics, Inc. INC Research Australia Pty Ltd · collab Nucleous Network · collab

RandomizedSequentialTriple-blindSupportive care

Summary

A Phase 1 study will test the safety, tolerability and pharmacokinetics of a single dose of GC4702 when given as an oral tablet. This study will compare capsules containing a dry powder or gel suspension of GC4702 when given orally to a similar drug called GC4419 which will be given as an intravenous infusion. This study will also assess the effect of food on the GC4702 effects.

Timeline

Start: 2016-07-26
Primary completion: 2016-12
Completion: 2016-12

Publications

Squillace S, Salvemini D. Nitroxidative stress in pain and opioid-induced adverse effects: therapeutic opportunities. Pain. 2022 Feb 1;163(2):205-213. doi: 10.1097/j.pain.0000000000002347. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GC4702	Unknown	50 mg	Oral
Subject	GC4702	Unknown	100 mg	Oral
Subject	GC4702	Unknown	112 mg	Oral
Subject	GC4702	Unknown	150 mg	Oral
Subject	GC4702	Unknown	224 mg	Oral
Subject	GC4702	Unknown	336 mg	Oral
Subject	GC4702	Unknown	448 mg	Oral
Subject	GC4702	Unknown	560 mg	Oral
Subject	GC4702	Unknown	—	Oral

Indications

No indication recorded.