NCT02837380

A Phase I Pharmacokinetic Study of Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 Microgram [mcg]) After Single and Repeat Dose Administration From a Dry Powder Inhaler in Healthy Chinese Subjects

An Open Label Study to Evaluate the Pharmacokinetics of Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 mcg) After Single and Repeat Dose Administration From a Dry Powder Inhaler in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is an open-label study to evaluate the PK of FF/UMEC/VI in dose combinations of 100/62.5/25 mcg after single and repeat dose administration from a DPI in healthy Chinese subjects. This study will evaluate the systemic pharmacokinetics (PK), of FF/UMEC/VI in Chinese healthy population when administered using dry powder inhaler (DPI)as a blended combination of UMEC/VI in one strip and FF in the second strip in dose combinations of 100/62.5/25 mcg. The triple, fixed dose combination product Fluticasone furoate(FF)/ Vilanterol (VI) /Umeclidinium bromide (UMEC) with new configuration enables the delivery of inhaled long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA) and inhaled corticosteroid (ICS) from a single device. Approximately 16 subjects will be enrolled in the study. After taking into account the allowable time windows for screening, treatment and follow-up, a subject will be in the study for a maximum duration of 6-7 weeks.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	FF	FF is a dry white powder blended with lactose. It is the first strip of DPI. Per blister contains 100 mcg of dose
DRUG	VI/UMEC	VI and UMEC bromide combination is a dry white powder blended with lactose and magnesium stearate. It is the second strip of DPI. Per blister contains 25 mcg/62.5 mcg of VI/UMEC dose

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-07-19
• Last updated: 2017-01-25

Locations

1 site across 1 country: China