Mass-balance Study of [14C]-APD421 in Healthy Volunteers

Phase 1 Completed 6 enrolled Acacia Pharma Ltd

NaSingle-groupOpen-labelTreatment

Summary

Open-label, non-randomised, single dose study in 6 healthy male subjects to assess the mass balance recovery, metabolite profile, metabolite identification and pharmacokinetics of 14C-labelled APD421

Timeline

Start: 2016-08
Primary completion: 2016-08
Completion: 2016-08

Publications

Fox GM, Roffel AF, Hartstra J, Bussian LA, van Marle SP. Metabolism and Excretion of Intravenous, Radio-Labeled Amisulpride in Healthy, Adult Volunteers. Clin Pharmacol. 2019 Dec 2;11:161-169. doi: 10.2147/CPAA.S234256. eCollection 2019.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Amisulpride	Small molecule	10 mg	Intravenous

Indications

No indication recorded.