A Study to Assess the Relative Bioavailability of Process Variants of Selumetinib in Healthy Male Volunteers

Summary

A Study to assess, against a reference selumetinib capsule, if the drug levels of a variant of selumetinib capsule are comparable, and to assess how drug levels differed in another variant of Selumetinib in Healthy Male Volunteers.

Timeline

Start

2015-02

Primary completion

2015-04

Completion

2015-04

Outcome

Missed primary endpoint

registry Geometric Least Squares (LS) Mean Ratio 9.32 (90% CI 8.25 to 10.53) NCT02322749 ↗

registry Geometric LS Mean Ratio 24.26 (90% CI 22.62 to 26.03) NCT02322749 ↗

registry Geometric LS mean ratio 22.12 (90% CI 20.65 to 23.69) NCT02322749 ↗

Drugs

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

Indications

No indication recorded.