Golden-7
Research type
Research Study
Full title
A Crossover Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of SUN-101 and Seebri® Breezhaler® Administered with and without Activated Charcoal in Subjects with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)(GOLDEN-7)
IRAS ID
184459
Contact name
Brian Leaker
Contact email
Sponsor organisation
Sunovion Respiratory Development Inc.
Eudract number
2015-002459-86
Duration of Study in the UK
0 years, 6 months, 6 days
Research summary
COPD (Chronic Obstructive Pulmonary Disease)is a progressive lung disorder that presents a major health problem as an important cause of morbidity, mortality, and burden on health care systems worldwide.
This is a randomised, open-label, single-dose per dosing period, five-way crossover Phase 1 clinical study which means a total of five treatments will be studied & these treatments are open-label, which means that both the participant and the study doctor will know which treatment they are taking.
The study drug SUN-101 is an inhalation solution formulation of glycopyrrolate for delivery using a nebuliser (Investigational eFlow nebuliser, PARI) for the long term, maintenance treatment of bronchoconstriction in patients with COPD who prefer nebuliser treatments or require nebuliser treatments for optimal treatment.
The purpose of the study is to compare the systemic absorption of Glycopyrrolate following three different formulations of the drug being administered. SUN-101 is a novel formulation of Glycopyrrolate administered via inhalation using a novel nebuliser device. Seebri Breezhaler device is an approved formulation administered via inhalation using a dry powder inhaler device. The Seebri Breezhaler will be the reference drug in this case. Both drugs will then be given with and without oral charcoal administration to determine the difference between systemic absorption following lung delivery. The charcoal will absorb any drug that is absorbed via the GI tract.
Finally the systemic absorption of the drugs can be compared with the pharmacokinetic profile following intravenous administration of Glycopyrrolate. The study design is a cross over so each patient will receive each treatment and the PK profiles can be compared for each modality. The comparison between inhaled and intravenous administration will also be used to determine the amount of drug that is absorbed directly in the lung but does not result in systemic absorptionAround 30 participants will be recruited from 1 UK site with participation expected to be 8 weeks.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
15/EE/0296
Date of REC Opinion
2 Oct 2015
REC opinion
Further Information Favourable Opinion