Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996874
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2023-08-10
Brief Title:
A Research Study Comparing the Effect of Different Dosing Conditions on Blood Levels of Semaglutide in a New Tablet Composition in Healthy Participants
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
Investigation of the Effect of Dosing Conditions on the Pharmacokinetics of New Oral Semaglutide Formulation in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2024-08
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:
In this study a known medicine called semaglutide will be tested in a new tablet version The medicine will be tested in healthy men to explore the effect of different water volumes and tablet-meal delays on blood levels of semaglutide after 10 days of oral administration Semaglutide tablets under the brand name Rybelsus are approved in the EU and USA for the treatment of type 2 diabetes Participants will get a daily treatment with dose 1 new oral semaglutide tablet for 5 days followed by another 5 days with a daily treatment of dose 2 new oral semaglutide tablet Participants will get one tablet each day for 10 days The tablet should be taken in the morning on an empty stomach with either 50 milliliter mL or 120mL water after an overnight fast of at least 6 hours no food or drinks Water is not allowed from 2 hours before dosing A predefined breakfast will be served either 30 60 or 120 minutes after taking tablet depending on the treatment received Breakfast will need to be eaten within 30 minutes Which treatment participants will get is decided by chance The study will last for about 11 weeks This will include a screening period up to 28 days a treatment period 10 days and a follow-up visit at least 5 weeks after the last dose Participants should not take any prescription or non-prescription medicines or herbal products including St Johns wort within 14 days prior to the screening visit and until the follow-up visit except for routine vitamins medicines applied on the skin and occasional use of paracetamol a mild pain killer No oral medication can be taken from 2 hours before and depending on the group participants are in until 30 60 or 120 minutes after each dosing with semaglutide
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1281-4819 | OTHER | None | None |
| 2022-002848-52 | EUDRACT_NUMBER | World Health Organization WHO | None |