Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Double-blind, Single Dose, Four Way Cross-over Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol Following Single Inhaled Doses of Umeclidinium/Vilanterol Blend + Fluticasone Furoate, Umeclidinium + Vilanterol, Fluticasone Furoate + Vilanterol and Fluticasone Furoate + Umeclidinium in Healthy Subjects
This is a double-blind, single dose (four inhalations), four-way cross over study in healthy
subjects that will assess the systemic pharmacokinetics (PK) and systemic pharmacodynamics
(PD) of Fluticasone Furoate, (FF), Umeclidinium, (UMEC) and Vilanterol (VI). Study drug will
be delivered through a novel single-step activation dry powder inhaler (NDPI) which has a two
strip configuration. The NDPI will be configured with different combinations of each compound
and also a new blend of UMEC/VI inhalation powder within a single strip of the NDPI device.
Study drug will be administered through the inhaled route to healthy subjects in single doses
(four inhalations). Each subject will receive treatment in a randomized order Treatment A FF
(400 microgram [µg]) and UMEC (500 µg)/VI (100 µg), Treatment B UMEC (500 µg) and VI (100
µg), Treatment C FF (400 µg) and VI (100 µg) and Treatment D FF (400 µg) and UMEC (500 µg)
over four treatment periods. Each treatment period will be separated by a washout of 7 to 21
days. After the four treatment periods, a follow up visit will take place 7 to 21 days
following the final dose of study medication and the maximum duration a subject will be
involved in the study is eighteen weeks.
Pharmacokinetics will be assessed by the measurement of plasma and urine concentrations of
FF, UMEC and VI. Safety and PD will be monitored using blood glucose, serum potassium, heart
rate, 12-lead ECGs and clinical laboratory tests. Plasma samples for PK will be collected
throughout the study, urine, blood glucose, serum potassium, heart rate, 12-lead ECGs and
clinical laboratory tests will be assessed on Day 1 only. AEs will be assessed throughout the
study.
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