NCT05995249

A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-279	TAK-279 capsules
DRUG	Erythromycin	Erythromycin tablets
DRUG	Phenytoin	Phenytoin capsules
DRUG	Efavirenz	Efavirenz tablets

Timeline

• Start date: 2023-08-11
• Primary completion: 2023-12-18
• Completion: 2023-12-31
• First posted: 2023-08-16
• Last updated: 2024-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study