A Study of RO5285119 in Healthy Volunteers

Phase 1 Completed 77 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blind

Summary

This two-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of RO5285119 in healthy volunteers. Anticipated time on study will be up to 9 weeks for each subject.

Timeline

Start: 2011-07
Primary completion: 2012-07
Completion: 2012-07

Publications

Derks M, Lennon-Chrimes S, Guenther A, Squassante L, Wandel C, Szczesny P, Paehler A, Kletzl H. Bioavailability and pharmacokinetic profile of balovaptan, a selective, brain-penetrant vasopressin 1a receptor antagonist, in healthy volunteers. Expert Opin Investig Drugs. 2021 Aug;30(8):893-901. doi: 10.1080/13543784.2021.1948009. Epub 2021 Jul 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Balovaptan	Small molecule	—	Oral

Indications

No indication recorded.