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

NCT02424799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2019-06-21

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-17
Primary Completion
2017-11-10
Completion
2017-11-10

Countries

  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02424799 on ClinicalTrials.gov