Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564441
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Study to Test Whether BI 456906 Survodutide Influences the Amount of Bupropion Caffeine and Midazolam in the Blood in People With Overweight or Obesity
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Non-randomised Fixed-sequence Two Period Phase I Trial to Evaluate the Effect of Different Doses of BI 456906 Survodutide on the Single Dose Pharmacokinetics of Bupropion Caffeine and Midazolam on Otherwise Healthy Volunteers With Overweight or Obesity
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is open to adults with overweight or obesity who are otherwise healthy People can join the study if they have a body mass index of 27 to 399 kgm2 and a body weight over 70 kg The purpose of this study is to find out whether taking multiple doses of BI 456906 influences the amount of bupropion caffeine and midazolam in the blood
The study has 2 treatment periods In Period 1 participants take 1 dose each of midazolam caffeine and bupropion as tablets or oral solution on separate days In Period 2 participants get BI 456906 as an injection under the skin once a week At 2 selected timepoints in Period 2 participants also take midazolam caffeine and bupropion as tablets or oral solution on separate days
Participants are in the study for about 13 months They visit the study site up to 45 times At 3 of those visits participants stay for 5 or 6 days at the study site During the visits doctors collect information about participants health and take blood samples from the participants They compare the amounts of midazolam caffeine and bupropion in the blood in Period 2 with the amounts in Period 1 Doctors also regularly check participants health and take note of any unwanted effects
The study has 2 treatment periods In Period 1 participants take 1 dose each of midazolam caffeine and bupropion as tablets or oral solution on separate days In Period 2 participants get BI 456906 as an injection under the skin once a week At 2 selected timepoints in Period 2 participants also take midazolam caffeine and bupropion as tablets or oral solution on separate days
Participants are in the study for about 13 months They visit the study site up to 45 times At 3 of those visits participants stay for 5 or 6 days at the study site During the visits doctors collect information about participants health and take blood samples from the participants They compare the amounts of midazolam caffeine and bupropion in the blood in Period 2 with the amounts in Period 1 Doctors also 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None