Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-29 @ 6:11 AM
Study NCT ID:
NCT06290050
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2024-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Phase 1, Open-Label, Drug-Drug Interaction Study to Assess the Effect of TAK-279 on the Pharmacokinetics of a Sensitive CYP3A4 Substrate and a Sensitive CYP2C8 Substrate in Healthy Subjects
Status:
COMPLETED
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:
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).
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.
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 Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: