Absorption & Elimination of Radiolabelled GSK2269557
Status:
Completed
Trial end date:
2017-12-22
Target enrollment:
Participant gender:
Summary
GSK2269557 is being developed as an anti-inflammatory agent for the treatment of chronic
obstructive pulmonary disease (COPD) and other inflammatory lung diseases such as asthma.
This study is designed to investigate the recovery, excretion, and pharmacokinetics (PK) of
(14 Carbon [C])-GSK2269557 administered as a single intravenous (IV) dose (concomitant with
an inhaled non-radiolabelled dose) and as a single oral dose in 6 healthy male subjects.
Subjects will receive [14C] radiolabelled GSK2269557 administered as IV infusion, with a
nonradiolabelled dose of GSK2269557 via dry powder inhaler (DPI) in treatment period 1 and a
single dose of [14C]-GSK2269557, administered as an oral solution in treatment period 2.
There will be a washout period of at least 14 days after inhaled and IV dosing before
subjects takes part in treatment period 2. The IV microtracer dose of GSK2269557 will be
administered concomitant to an inhaled non-radiolabelled dose to ensure that the
pharmacokinetics represent a clinically relevant dose. The total study duration will be up to
11 weeks, including a screening visit, 2 treatment periods and a follow-up visit.