Selection and Optimization of Two Oral Formulations (QSC202103)
Research type
Research Study
Full title
Formulation selection and subsequent optimization of two different oral formulations of BI 894416 in healthy male subjects (open-label, randomised, single-dose study in two parts; trial part 1: five-period crossover design with an additional sixth period in a fixed sequence; trial part 2: three-period crossover followed by a two-period crossover design)
IRAS ID
270004
Contact name
Sue Clark
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2019-003424-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 4 days
Research summary
Research Summary:
The Sponsor, Boehringer Ingelheim, are developing the test medicine, BI 894416, for the potential treatment of asthma. Asthma is a common lung condition that causes occasional breathing difficulties characterized by reoccurring inflammation of the airways. It affects people of all ages and often starts in childhood, although it can also develop for the first time in adults.This study will consist of two parts. Part 1 will investigate how the body reacts to new formulations (recipes) of the test medicine. Part 2 is optional based on the results from Part 1, and will investigate optimized formulations of the test medicine.
Part 1 consists of one study period with six dosing occasions involving up to 24 healthy male volunteers. On dosing occasions 1-5, volunteers will receive a single dose of the test medicine in the fasted state. In dosing occasion six, volunteers will receive a single dose of a previous formulation in the fed state.
Part 2 is optional and consists of up to two parts involving up to 18 healthy male volunteers. For Part 2A, there are three dosing occasions where volunteers will receive a single dose of the test medicine in the fed or fasted state. An optional Part 2B will consist of two dosing occasions where volunteers will receive one dose of the test medicine in the fed or fasted state. In both parts, there will be at least a 4-day washout period between dosing occasions.
For Part 1, Part 2A and/or Part 2B volunteers will have a follow up visit 8-15 days after their final dose to ensure their continued wellbeing. Should trial Part 2B follow within 28 days after end of trial examination of Part 2A, no additional safety laboratory examination is needed.
Summary of Results:
The study was done with healthy people who volunteered to participate.We thank all study participants. You helped us to answer important questions about BI 894416.
What was this study about?
The purpose of this study was to find out how much BI 894416 gets into the blood when it is taken as a tablet or a capsule. BI 894416 is a medicine that was being developed to treat people with asthma. When we develop a new medicine, we need to understand how much of it gets into the blood. Studies in healthy people help us answer this question.
The study was stopped early because the sponsor decided not to study BI 894416 any further for the treatment of asthma.Who took part in this study?
24 healthy men took part in the study. The youngest participant was 21 years old, and the oldest participant was 55 years old.
This study was done in the United Kingdom.How was this study done?
During the study, each participant took 6 separate treatments. There had to be at least 4 days between each treatment. The order in which each treatment was taken was not the same for each participant.
The treatments were:
• BI 894416 tablet, ‘fast release’ formulation, taken on an empty stomach
• BI 894416 tablet, ‘slow release’ formulation, taken on an empty stomach
• BI 894416 capsule, ‘fast release’ formulation, taken on an empty stomach
• BI 894416 capsule, ‘slow release’ formulation, taken on an empty stomach
• BI 894416 tablet, ‘slow release’ formulation, taken after eating a meal
• BI 894416 capsule, ‘slow release’ formulation, taken after eating a mealThe doctors took blood samples after the participants took each treatment. The doctors also collected information about the participants’ health.
A second part of the study was planned but was not done because the study was stopped early.
What were the results of this study?
This study showed that the amount of BI 894416 in the blood was about the same, no matter whether it was taken as a tablet or a capsule, and as a ‘fast release’ formulation or a ‘slow release’ formulation. The amount of BI 894416 in the blood was higher when it was taken with a meal.
Did the participants have any unwanted effects?
Yes, participants in this study had unwanted effects. Unwanted effects are any health problems that the doctors think were caused by BI 894416. In this study, 7 out of 24 participants (29%) had unwanted effects. The most common unwanted effects were pain in the belly (abdominal discomfort), nausea, and drowsiness (lethargy).
None of the unwanted effects were serious. This means that the unwanted effects did not lead to a hospital stay, that they were not life-threatening, and that they did not lead to a disability.
Where can I find more information about this study?
The study number is 1371-0022 and the EudraCT number for this study is 2019-003424-21. For more information about the study, go to https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=04%7C01%7Capprovals%40hra.nhs.uk%7C74230bc737e3465dd3fe08d9b0d058a3%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637735231148078899%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=HpRRwjXgMiTvLtcqAazXkJj5WWjqnM%2Bbhu2SoyiDGxY%3D&reserved=0 and search for the NCT number NCT04232839.Boehringer Ingelheim sponsored this study.
REC name
Wales REC 2
REC reference
20/WA/0005
Date of REC Opinion
17 Jan 2020
REC opinion
Favourable Opinion