Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352411
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-03
Brief Title:
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Pharmacokinetics Safety and Tolerability of BI 456906 Following Subcutaneous Injection in Male and Female Participants With Mild Moderate and Severe Renal Impairment in Comparison to Participants With Normal Renal Function Mono-centric Open-label Study With Parallel Matched-pair Design
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is open to adults aged between 18 and 80 years of age with a body mass index BMI of 20 to 40 kgm2 People with or without kidney problems can take part in the study
The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems BI 456906 is being developed to treat people with obesity and liver problems People living with these conditions often also have kidney problems Therefore it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood
Study participants receive a single dose of BI 456906 as an injection under the skin Participants are divided into 4 groups based on how well their kidneys work 1 group without kidney problems and 3 groups with mild moderate and severe kidney problems Each participant without kidney problems is matched with participants from the other groups based on factors such as age gender race and body mass index BMI to ensure accurate comparisons
Participants are in the study for about 2 months They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times During these visits the doctors collect information about participants health To assess the study endpoints the doctors regularly take blood samples from the participants The participants also answer questions about their well-being The doctors regularly check participants health and take note of any unwanted effects
The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems BI 456906 is being developed to treat people with obesity and liver problems People living with these conditions often also have kidney problems Therefore it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood
Study participants receive a single dose of BI 456906 as an injection under the skin Participants are divided into 4 groups based on how well their kidneys work 1 group without kidney problems and 3 groups with mild moderate and severe kidney problems Each participant without kidney problems is matched with participants from the other groups based on factors such as age gender race and body mass index BMI to ensure accurate comparisons
Participants are in the study for about 2 months They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times During these visits the doctors collect information about participants health To assess the study endpoints the doctors regularly take blood samples from the participants The participants also answer questions about their well-being The doctors regularly check participants health and take note of any unwanted effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-508557-13-00 | REGISTRY | None | None |
| U1111-1298-3135 | REGISTRY | WHO registry | None |