Drug-Drug Interaction of Darunavir/Ritonavir on Pitavastatin

NCT01422369 ↗

Phase 4 Completed 28 enrolled Kowa Research Institute, Inc.

Non-randomizedSingle-groupOpen-label

Summary

This is a Phase 4, single center, open label, fixed-sequence, multiple dose, 2-way drug-drug interaction study.

Timeline

Start: 2011-04
Primary completion: 2011-06
Completion: 2011-06

Outcome

Mixed primary results

paper The primary objective was to investigate the steady-state pharmacokinetics of pitavastatin when co-administered with darunavir/ritonavir. PMID 24825411 ↗

paper For pitavastatin, the GMRs and 90 % CIs for the AUC(0-τ) and C(max) ratios with co-administration were 0.74 (0.69-0.80) and 0.96 (0.84-1.09), respectively. PMID 24825411 ↗

paper of the two treatments were within the 80-125 % range. PMID 24825411 ↗

Publications

Yu CY, Campbell SE, Sponseller CA, Small DS, Medlock MM, Morgan RE. Steady-state pharmacokinetics of darunavir/ritonavir and pitavastatin when co-administered to healthy adult volunteers. Clin Drug Investig. 2014 Jul;34(7):475-82. doi: 10.1007/s40261-014-0198-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darunavir	Small molecule	800 mg	—
Subject	Pitavastatin	Small molecule	4 mg	—
Subject	Ritonavir	Other / unclassified	100 mg	—

Indications

No indication recorded.