Investigation of Ritonavir Effects on Afatinib Exposure in Healthy Subjects

Summary

To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration

Timeline

Start

2011-08

Primary completion

2011-12

Completion

—

Outcome

Missed primary endpoint

registry Afatinib vs Afatinib + Concomittant Rtv; p = 0.1009; Geometric mean ratio 119.30 (90% CI 112.239 to 126.811); ANOVA; note: P-value for ratio outside interval 0.8-1.25 NCT01426958 ↗

registry Afatinib vs Afatinib + Concomittant Rtv; p = 0.0702; Geometric mean ratio 118.56 (90% CI 111.712 to 125.822); ANOVA; note: P-value for ratio outside interval 0.8-1.25 NCT01426958 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Afatinib	Small molecule	40 mg	Oral
Subject	Ritonavir	Other / unclassified	—	Oral

Indications

No indication recorded.