drugset

drugset / Trial / NCT01974349

To Assess the Effect of Food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

NCT01974349 ↗

Phase 1 Completed 39 enrolled AstraZeneca

RandomizedCrossoverOpen-labelBasic science

Summary

Study to assess the effect of food on the Pharmacokinetics of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Healthy Male Volunteers

Timeline

Start: 2013-11
Primary completion: 2014-02
Completion: 2014-02

Publications

Tomkinson H, McBride E, Martin P, Lisbon E, Dymond AW, Cantarini M, So K, Holt D. Comparison of the Pharmacokinetics of the Phase II and Phase III Capsule Formulations of Selumetinib and the Effects of Food on Exposure: Results From Two Randomized Crossover Trials in Healthy Male Subjects. Clin Ther. 2017 Nov;39(11):2260-2275.e1. doi: 10.1016/j.clinthera.2017.08.022. Epub 2017 Oct 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Selumetinib	Small molecule	75 mg	Oral

Indications