Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264

Summary

This First Time in Human (FTIH) study, which will be performed in three parts, is designed to investigate the safety, local tolerability, pharmacokinetics and pharmacodynamics after single and repeat topical applications of up to 2 strengths of GSK2646264 and corresponding placebo within the same subject, in healthy adult subjects (Part A), subjects with cold urticaria (CU, Part B) and subjects with chronic spontaneous urticaria (CsU, Part C). The study will also measure short term effects of GSK2646264 on the number and size of weals in subjects with CsU, and in healthy subjects and subjects with CU following provocation tests.

Timeline

Start

2014-11-17

Primary completion

2017-11-10

Completion

2017-11-10

Publications

• Dickson MC, Walker A, Grattan C, Perry H, Williams N, Ratia N, Dewit O, Gisbert S, Metz M, Maurer M. Effects of a topical treatment with spleen tyrosine kinase inhibitor in healthy subjects and patients with cold urticaria or chronic spontaneous urticaria: Results of a phase 1a/b randomised double-blind placebo-controlled study. Br J Clin Pharmacol. 2021 Dec;87(12):4797-4808. doi: 10.1111/bcp.14923. Epub 2021 Jun 18.

Drugs

Indications