NCT01934153

Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to characterize the pharmacokinetics (PK), safety and tolerability of topically applied umeclidinium following single dose topical administration. The results from this study will be used to 1) improve our understanding of the risk of systemic accumulation upon chronic administration, 2) support dosing recommendations in a 2a/2b study for axillary administration and, potentially, a separate combined 2a/2b study for palmar administration, and 3) confirm whether the same formulation can be used for axillary and palmar application for the next studies.

Conditions

• Hyperhidrosis

Interventions

Type	Name	Description
DRUG	[14C]Umeclidinium 18.5 mg	Umeclidinium will be supplied as clear, colorless solution, free from visible particulates, single dose, topical solution in clear glass jars. Dosage of 18.5 mg of Umeclidinium per gram is equivalent to 22 mg per gram of the bromide salt.

Timeline

• Start date: 2013-09-02
• Primary completion: 2014-02-19
• Completion: 2014-02-19
• First posted: 2013-09-04
• Last updated: 2017-05-15

Locations

1 site across 1 country: Netherlands