Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT06290050
Brief Summary:
The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide.
During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).
Detailed Description:
The drug being tested in this study is called TAK-279. The study will assess the potential effect of TAK-279 on cytochrome P450 (CYP) 3A4 using the probe substrate midazolam and the potential effect of TAK-279 on CYP2C8 using the probe substrate repaglinide in healthy participants.
The study will enroll approximately 20 participants. Participants will be enrolled in one of the four treatments.
* Treatment A: Midazolam 2 milligram (mg)
* Treatment B: Repaglinide 0.5 mg
* Treatment A + Treatment C: Midazolam 2 mg + TAK-279 Dose 1
* Treatment B + Treatment C: Repaglinide 0.5 mg + TAK-279 Dose 1
This single-center trial will be conducted in the United States. The overall study duration is approximately 59 days including screening period and follow-up.
Study:
NCT06290050
Study Brief:
Protocol Section:
NCT06290050