A scintigraphy study of S-770108 in healthy volunteers
Research type
Research Study
Full title
A phase one open label, crossover study in healthy adult subjects to quantify lung deposition and distribution of 99mTc radiolabelled S-770108 inhalation powder formulation delivered by the ICOcap® dry powder inhaler
IRAS ID
308628
Contact name
Aarifah Bijabhai
Contact email
Sponsor organisation
Shionogi B.V. (London Office)
Eudract number
2021-006296-42
Duration of Study in the UK
0 years, 1 months, 27 days
Research summary
This study is a single-dose, crossover, open-label, randomised gamma scintigraphy study investigating the deposition in the lungs and distribution of a dry powder formulation of S-770108 when administered from the ICOcap® dry powder inhaler device.
S-770108 is a combination of pirfenidone, magnesium stearate and lactose carrier in an inhalable formulation meaning that it can be breathed in rather than swallowed. This drug is being developed for the treatment and management of idiopathic pulmonary fibrosis (IPF) which is a chronic lung disease characterised by progressive decline in lung function and difficulty breathing.
The main objectives of the study are as follows:
- To investigate the distribution of the study drug (S-770108) in the lungs from a dry powder inhaler device following inhalation at 2 different targeted peak inspiratory flow rates (measure of the maximum amount of air that can be inhaled over the time course of 1 deep breath).- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of S-770108 when it is administered as a single dose on 2 occasions at two different peak inspiratory flow rates.
To facilitate determination of how much of the drug gets into the lungs and the distribution pattern, a technique called gamma scintigraphy will be used. Gamma scintigraphy is an imaging technique for detecting and quantifying a radiolabelled tracer inside the body which can track how a drug is distributed in the body.
The study will involve the following visits: 1 screening visit, 2 treatment period (around 3 days in duration each, separated by a 5-13 day washout period) and a post-study follow up visit 7-15 days after the last dose. The study population will be 12 healthy volunteers (males and females of both childbearing and non-childbearing potential).
REC name
Wales REC 1
REC reference
21/WA/0384
Date of REC Opinion
8 Dec 2021
REC opinion
Favourable Opinion