Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)

Summary

Study KCC-SMT-002, is a Phase 1, single-site, open-label, non-randomized, crossover, flexible dose design study to investigate the pharmacokinetic (PK) and safety comparing the Sofusa™ system with sumatriptan (KC5010) to Imitrex® oral tablets in 17 healthy volunteers.

Timeline

Start

2018-01-17

Primary completion

2018-03-28

Completion

2018-03-28

Publications

• Background Kam KR, Walsh LA, Bock SM, Koval M, Fischer KE, Ross RF, Desai TA. Nanostructure-mediated transport of biologics across epithelial tissue: enhancing permeability via nanotopography. Nano Lett. 2013 Jan 9;13(1):164-71. doi: 10.1021/nl3037799. Epub 2012 Dec 24.
• Background Walsh L, Ryu J, Bock S, Koval M, Mauro T, Ross R, Desai T. Nanotopography facilitates in vivo transdermal delivery of high molecular weight therapeutics through an integrin-dependent mechanism. Nano Lett. 2015 Apr 8;15(4):2434-41. doi: 10.1021/nl504829f. Epub 2015 Mar 27.
• Background Owen K, Hartley K, Tucker ML, Parkinson MM, Tweats DJ, Jackson MR. The preclinical toxicological evaluation of sumatriptan. Hum Exp Toxicol. 1995 Dec;14(12):959-73. doi: 10.1177/096032719501401205.

Drugs

Indications