Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05995249
Status:
COMPLETED
Last Update Posted:
2024-02-06
First Post:
2023-08-09
Brief Title:
A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Phase 1 3-Part Open-label Drug-Drug Interaction Study to Evaluate the Effect of a Moderate CYP3A4 Inhibitor and of Strong and Moderate CYP3A4 Inducers on the Pharmacokinetics of TAK-279 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2024-02
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 the body of a healthy adult processes TAK-279 pharmacokinetics when substances that either hinder or help the human metabolism such as erythromycin phenytoin and efavirenz are given along with TAK-279 Other aim is to learn about side effects and how well it is tolerated when TAK-279 is given alone and together with substances that impact human metabolism
The participants will need to stay at the clinic for up to 26 days
The participants will need to stay at the clinic for up to 26 days
Detailed Description:
The drug being tested in this study is called TAK-279 TAK-279 is being tested to assess the effect of a moderate CYP3A4 inhibitor erythromycin- Part 1 and of strong phenytoin- Part 2 and moderate efavirenz- Part 3 CYP3A4 inducers on the pharmacokinetics of TAK-279 in healthy participants
The study will enroll approximately 48 patients Participants will be enrolled in one of the three parts to receive a single dose of TAK-279 in both Period 1 and Period 2 along with multiple doses of either erythromycin phenytoin or efavirenz in Period 2 as given below
Part 1 Treatment A Treatment B TAK-279 50 mg Erythromycin 500 mg
Part 2 Treatment C Treatment D TAK-279 50 mg Phenytoin 100 mg
Part 3 Treatment E Treatment F TAK-279 50 mg Efavirenz 600 mg
All participants will be monitored for up to 14 days postdose in each Part
This single-center trial will be conducted in the United States The overall study duration is approximately 65 days for Part 1 73 days for Part 2 and 70 days for Part 3
The study will enroll approximately 48 patients Participants will be enrolled in one of the three parts to receive a single dose of TAK-279 in both Period 1 and Period 2 along with multiple doses of either erythromycin phenytoin or efavirenz in Period 2 as given below
Part 1 Treatment A Treatment B TAK-279 50 mg Erythromycin 500 mg
Part 2 Treatment C Treatment D TAK-279 50 mg Phenytoin 100 mg
Part 3 Treatment E Treatment F TAK-279 50 mg Efavirenz 600 mg
All participants will be monitored for up to 14 days postdose in each Part
This single-center trial will be conducted in the United States The overall study duration is approximately 65 days for Part 1 73 days for Part 2 and 70 days for Part 3
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?:
None
Is an FDA AA801 Violation?:
None