Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects

Phase 1 Completed 64 enrolled Calliditas Therapeutics AB

Non-randomizedSingle-groupOpen-labelOther

Summary

The study is a monocentric, open label, phase 1 study to evaluate the pharmacokinetics, and in particular the dose proportionality of setanaxib and its metabolites after a single oral dose (400 mg, 800 mg, 1200 mg, and 1600 mg) (Part 1) and after multiple oral doses (Part 2).

Timeline

Start: 2020-06-24
Primary completion: 2021-03-23
Completion: 2021-03-23

Publications

Gage MC, Thippeswamy T. Inhibitors of Src Family Kinases, Inducible Nitric Oxide Synthase, and NADPH Oxidase as Potential CNS Drug Targets for Neurological Diseases. CNS Drugs. 2021 Jan;35(1):1-20. doi: 10.1007/s40263-020-00787-5. Epub 2021 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Setanaxib	Small molecule	400 mg	Oral
Subject	Setanaxib	Small molecule	800 mg	Oral
Subject	Setanaxib	Small molecule	1200 mg	Oral
Subject	Setanaxib	Small molecule	1600 mg	Oral

Indications

No indication recorded.