A Clinical Study to Determine Biomarkers of Response to a Gamma Secretase Inhibitor

Phase 1 Completed 30 enrolled Merck Sharp & Dohme LLC

RandomizedCrossoverDouble-blindDiagnostic

Summary

The purpose of this study is to determine the transcriptional signature of Notch Inhibition by testing hair and blood samples on healthy male volunteers who have received MK0752 vs placebo for possible future biomarkers in the treatment of cancer or Alzheimers Disease

Timeline

Start: 2008-12
Primary completion: 2009-01
Completion: 2009-01

Publications

Results Tanis KQ, Podtelezhnikov AA, Blackman SC, Hing J, Railkar RA, Lunceford J, Klappenbach JA, Wei B, Harman A, Camargo LM, Shah S, Finney EM, Hardwick JS, Loboda A, Watters J, Bergstrom DA, Demuth T, Herman GA, Strack PR, Iannone R. An accessible pharmacodynamic transcriptional biomarker for notch target engagement. Clin Pharmacol Ther. 2016 Apr;99(4):370-80. doi: 10.1002/cpt.335. Epub 2016 Feb 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	MK-0752	Small molecule	350 mg	—
Comparator	MK-0752	Small molecule	1000 mg	—

Indications

No indication recorded.