NCT02424799

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

A Randomised Double Blind (Sponsor Unblinded), Single and Repeat Ascending Dose First Time in Human Study in Healthy Subjects, Cold Urticaria and Chronic Spontaneous Urticaria Subjects to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urticaria

Interventions

Type	Name	Description
DRUG	GSK2646264 0.5% topical cream	GSK2646264 0.5% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars
DRUG	GSK2646264 1% topical cream	GSK2646264 1% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars
DRUG	Placebo	Placebo topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars

Timeline

• Start date: 2014-11-17
• Primary completion: 2017-11-10
• Completion: 2017-11-10
• First posted: 2015-04-23
• Last updated: 2019-06-21
• Results posted: 2019-06-21

Locations

6 sites across 2 countries: Germany, United Kingdom