Safety, Tolerability, PK and Efficacy of Single Doses of NV-5138 in Healthy Volunteers and Subjects With Treatment-Resistant Depression

Phase 1 Completed 80 enrolled Navitor Pharmaceuticals, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Randomized, two-part, placebo-controlled study of single ascending doses of NV-5138 in healthy volunteers, and a single dose of NV-5138 in subjects with Treatment-Resistant Depression (TRD)

Timeline

Start: 2018-06-06
Primary completion: 2019-06-09
Completion: 2019-07-07

Publications

Targum SD, Sanacora G, Formella AE, Ceresoli-Borroni G, Owen R. A novel, experimental design to assess rapid antidepressant action: Results from a phase 1b randomized trial of NV-5138. J Psychiatr Res. 2026 Mar;194:211-220. doi: 10.1016/j.jpsychires.2026.01.006. Epub 2026 Jan 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	NV-5138	Small molecule	150 mg	Oral
Subject	NV-5138	Small molecule	300 mg	Oral
Subject	NV-5138	Small molecule	600 mg	Oral
Subject	NV-5138	Small molecule	1000 mg	Oral
Subject	NV-5138	Small molecule	1600 mg	Oral
Subject	NV-5138	Small molecule	2400 mg	Oral

Indications

No indication recorded.