A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers

Phase 1 Completed 16 enrolled Hoffmann-La Roche

Non-randomizedSingle-groupOpen-labelOther

Summary

This study was a single-center, non-randomized, open-label, one-sequence, two-period, within-subject study to investigate the effects of multiple doses of rifampicin on the PK and safety of multiple doses of balovaptan in healthy subjects. The study was conducted at 1 site in the Netherlands.

Timeline

Start: 2018-07-24
Primary completion: 2018-11-02
Completion: 2018-11-15

Publications

Derks MGM, Wandel C, Young A, Bolt SK, Meyenberg C. Open-Label Assessment of the Effects of Itraconazole and Rifampicin on Balovaptan Pharmacokinetics in Healthy Volunteers. Adv Ther. 2020 Nov;37(11):4720-4729. doi: 10.1007/s12325-020-01491-y. Epub 2020 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Balovaptan	Small molecule	5 mg	—
Subject	Balovaptan	Small molecule	10 mg	—
Subject	Rifampin	Small molecule	600 mg	—

Indications

No indication recorded.