A study to investigate the lung deposition of PT003
Research type
Research Study
Full title
A Randomized, Single-blind, Two-treatment, Single-dose, Single-center, Placebo-controlled, Crossover Gamma Scintigraphy Study to Assess the Pulmonary Deposition of 99mTc Radiolabeled Glycopyrronium and Formoterol Fumarate MDI and Placebo MDI in Healthy Male Subjects
IRAS ID
189218
Contact name
Mae-Le Sit
Contact email
Sponsor organisation
Pearl Therapeutics, Inc
Eudract number
2015-003671-30
Duration of Study in the UK
0 years, 0 months, 19 days
Research summary
This study study is a 2 way crossover design, assessing the amount of a new drug formulation, called PT003, which gets into the lungs after a single dose from an inhaler, assessed to a single dose from a placebo inhaler in approximately 10 healthy males.
PT003 contains a combination of 2 marketed drugs called Glycopyrronium and Formoterol Fumarate. Glycopyrronium is marketed in many countries in multiple formulations for treating different respiratory illnesses. Formoterol Fumarate is also marketed in many countries worldwide and is also used for treating different respiratory illnesses.
To enable us to determine how much of the formulation gets into the lung, a technique called gamma scintigraphy will be used. Gamma scintigraphy is a technique used to track the movement of a radiolabelled tracer inside the body.
By assessing the amount of PT003 and placebo in the lungs we will be able to see if PT003 gets into the lung in a similar way to the placebo.
The study will involve the following visits: 1 screening visits, 2 treatment visits, each separated by a minimum of 5 days (each with 2 overnight stays; from the evening before dosing until a maximum of 24 hours post-dose on the morning of Day 2) and a final post-study follow-up visit.
The population who are eligible to take part in the study are healthy males aged between 18 and 50 years, as identified by screening procedures at Simbec.
REC name
Wales REC 2
REC reference
15/WA/0326
Date of REC Opinion
7 Oct 2015
REC opinion
Further Information Favourable Opinion