A scintigraphy study of GDC-0214 DPI in healthy adult volunteers
Research type
Research Study
Full title
Open label, uncontrolled, non-randomized, single dose, scintigraphic study to investigate lung deposition of inhaled 99mTc radiolabelled GDC-0214 DPI in healthy adult volunteers.
IRAS ID
268917
Contact name
Ezanul Wahab
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2019-002630-36
Duration of Study in the UK
0 years, 1 months, 0 days
Research summary
Research Summary
This study is a single-dose, open-label, non-randomised gamma scintigraphy study investigating the deposition in the lungs and distribution of GDC-0214 when administered from a dry powder inhaler.GDC-0214 is a small molecule inhibitor combined with lactose (sugar based powder) enclosed in a hard capsule 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 asthma which is a long term chronic lung disease characterised by inflammation in the lungs causing difficulty in breathing and frequent attacks.
The purpose of this study is to assess the deposition and distribution pattern of GDC-0214 in the lungs and to determine the efficiency of delivery of GDC-0214 from the inhaler device.
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 a technique for detecting and quantifying a radiolabelled
tracer inside the body.The study will involve the following visits: 1 screening visit, 1 treatment visit (around 1 day in duration) and a post-study follow up visit 7-14 days after the dose.
The population for this study is 12 healthy male and females (of non child bearing potential).
Summary of Results
The purpose of this study was to investigate the distribution of the study drug (GDC-0214) in the lungs when administered from a dry powder inhaler (DPI) device and to evaluate the safety of GDC-0214.The study evaluated how much of the drug was distributed in the lungs after a single dose from the inhaler and how the levels of the drug changed in the blood over a period of time in healthy volunteers.
GDC-0214 is being developed for the treatment of asthma which is a chronic lung condition associated with inflammation in the airways, difficulty breathing and frequent attacks.
This study drug contained the active product GDC-0214 (1 milligram in every 20-milligram capsule) and a lactose carrier (sugar-based powder) which helped in the delivery of the drug into the lungs.
This study was not a first in human study, GDC-0214 has been given to humans previously including healthy volunteers and asthma patients. The drug was administered via a DPI which is an inhaler device that delivers the drug to the lungs by piercing a hard capsule containing the powder and allowing it to be inhaled.
To enable the determination of how much of the drug gets into the lungs, a technique called gamma scintigraphy was used. Gamma scintigraphy is a technique which uses a camera to detect and measure a radiolabelled tracer inside the body. In this case, the study drug GDC-0214 was labelled with a small amount of radioactivity that allowed the drug to be visible in the lungs when the camera scanned the body.
With respect to the safety objectives of the study, it was determined that the dose of GDC-0214 was considered to be safe and well tolerated. There were no adverse events (side effects) reported during the study which were considered related to the study drug.
With respect to the evaluation of the distribution of the drug in the lungs and the measurement of the levels of the study drug in the blood, the following outcomes were reported:
- The study drug was distributed in the lungs amongst all participants in the study in an efficient and similarly produced pattern.
- The drug was shown to distribute in both the inner and outer areas of lungs as desired.
- The inhaler device was shown to deliver the dose efficiently, releasing an appropriate dosage of the study drug.
- The levels of the study drug measured in the blood were observed to be equivalent to that which were measured within the previous clinical trial of GDC-0214.In summary, the data gathered during the study was considered sufficient to meet the objectives of the study and warrant further clinical trials and investigations of the study drug.
REC name
Wales REC 2
REC reference
19/WA/0218
Date of REC Opinion
16 Aug 2019
REC opinion
Favourable Opinion