Effect of Ridaforolimus on the Pharmacokinetics of Midazolam (Study MK-8669-044)

Summary

The purpose of this study is to compare the pharmacokinetic profile of midazolam given alone and midazolam given after multiple oral doses of 40 mg ridaforolimus. Part 1 of this study is designed for evaluating CYP3A4 activity following 5 days of dosing of ridaforolimus and is not designed with efficacy endpoints. Part 2 is a compassionate-use extension to give patients an opportunity to receive a clinically active dose of ridaforolimus. Part 2 dosing is open ended with limited data collection.

Timeline

Start

2010-03

Primary completion

2010-09

Completion

2012-02

Publications

• Results Stroh M, Talaty J, Sandhu P, McCrea J, Patnaik A, Tolcher A, Palcza J, Orford K, Breidinger S, Narasimhan N, Panebianco D, Lush R, Papadopoulos KP, Wagner JA, Trucksis M, Agrawal N. Lack of meaningful effect of ridaforolimus on the pharmacokinetics of midazolam in cancer patients: model prediction and clinical confirmation. J Clin Pharmacol. 2014 Nov;54(11):1256-62. doi: 10.1002/jcph.331. Epub 2014 May 24.

Drugs

Indications