Antineoplastic Agents

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Dabrafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Two capsules each containing 75 mg GSK2118436, followed by a single IV dose of 50 ug (no more than 7.4 kBq or 200 nCi) \[14C\]GSK2118436, starting 1.75 hours after the oral dose

GSK2118436

GSK Clinical Trials

GSK2118436 is an orally administered, potent and selective small molecule BRAF inhibitor that is currently being developed for the treatment of BRAF mutation-positive tumors. This is an open-label, non-randomized study designed to determine the absolute bioavailability of an oral dose of 150 mg of GSK2118436 co-administered with an intravenous 50 microgram dose of \[14C\]GSK2118436 in subjects with BRAF mutant solid tumors. Pharmacokinetic samples will be obtained up to 72 hours post-dose. Safety assessments will be performed throughout the study. After completing all assessments, eligible subjects may transition to BRF114144, an open-label, rollover study of GSK2118436 to continue treatment.

Determination of the Absolute Bioavailability of GSK2118436 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microtracer of GSK2118436 in Subjects With BRAF Mutant Solid Tumors

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Determination of the Absolute Bioavailability of GSK2118436 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microtracer of GSK2118436 in Subjects With BRAF Mutant Solid Tumors	NCT01340833	Cancer	GSK2118436	18 Years -	GlaxoSmithKline
Determination of the Absolute Bioavailability of GSK2118436 Following a Single Oral Dose Co-Administered With an Intravenous Radiolabelled Microtracer of GSK2118436 in Subjects With BRAF Mutant Solid Tumors	NCT01340833	Cancer	GSK2118436	18 Years -	GlaxoSmithKline

Spots Global Cancer Trial Database for absolute bioavailability