A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers

Phase 1 Completed 18 enrolled Hoffmann-La Roche

RandomizedCrossoverOpen-label

Summary

This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.

Timeline

Start: 2011-12
Primary completion: 2012-02
Completion: 2012-02

Publications

Brennan BJ, Moreira SA, Morcos PN, Navarro MT, Asthappan J, Goelzer P, Weigl P, Smith PF. Pharmacokinetics of a three-way drug interaction between danoprevir, ritonavir and the organic anion transporting polypeptide (OATP) inhibitor ciclosporin. Clin Pharmacokinet. 2013 Sep;52(9):805-13. doi: 10.1007/s40262-013-0077-2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	100 mg	Oral
Subject	Ritonavir	Other / unclassified	100 mg	Oral
Subject	danoprevir	Small molecule	100 mg	Oral

Indications

No indication recorded.