Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers

Phase 1 Completed 34 enrolled Boehringer Ingelheim

RandomizedCrossoverOpen-labelTreatment

Summary

The objective of the current study is to investigate the relative bioavailability of a single dose of nintedanib low or high dose with and without coadministration of ketoconazole at steady state

Timeline

Start: 2012-09
Primary completion: 2012-11
Completion: 2012-11

Outcome

Missed primary endpoint

registry Geometric Mean Ratio in percentage 160.48 (90% CI 148.245 to 173.736); ANOVA; note: p-value for ratio outside interval 0.8 - 1.25 NCT01679613 ↗

registry Geometric Mean Ratio in percentage 179.62 (90% CI 157.557 to 204.779); ANOVA; note: p-value for ratio outside interval 0.8 - 1.25 NCT01679613 ↗

Publications

Luedtke D, Marzin K, Jungnik A, von Wangenheim U, Dallinger C. Effects of Ketoconazole and Rifampicin on the Pharmacokinetics of Nintedanib in Healthy Subjects. Eur J Drug Metab Pharmacokinet. 2018 Oct;43(5):533-541. doi: 10.1007/s13318-018-0467-9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketoconazole	Small molecule	400 mg	Oral
Subject	Nintedanib	Small molecule	50 mg	Oral

Indications

No indication recorded.