Characterization of Exposure From Topical Administration of [14C] Umeclidinium to Axilla or Palm of Healthy Male Subjects
Status:
Completed
Trial end date:
2014-02-19
Target enrollment:
Participant gender:
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.