At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 34 enrolled

Drug / intervention

GSK2646264 0.5% topical cream +2 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02424799

NCT02424799Phase 1Completed

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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

GlaxoSmithKline·interventional·Posted Apr 23, 2015·Updated Jun 21, 2019

In Brief

A Phase 1 clinical trial evaluating GSK2646264 0.5% topical cream, GSK2646264 1% topical cream, and 1 other intervention for Urticaria. Completed, enrolled 34 participants across 6 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsUrticaria

CountriesGermany, United Kingdom

Collaborators--

Timeline

Phase 1CompletedFinished

201520162017201820192020202120222023202420252026

Enrollment StartNov 2014

First PostedApr 2015

Primary CompletionNov 2017

TodayJul 2026

First PostedApr 23, 2015

Enrollment StartNov 17, 2014

Primary CompletionNov 10, 2017

TodayJul 2, 2026

Enrollment to primary: 3.0 yearsPosted 11.2 years ago

Interventions

GSK2646264 0.5% topical creamdrug

GSK2646264 0.5% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars

GSK2646264 1% topical creamdrug

GSK2646264 1% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars

Placebodrug

Placebo topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars