A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05995249
- Lead Sponsor
- Takeda
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 172
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg TAK-279 Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study. Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg TAK-279 Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study. Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg TAK-279 Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study. Part 1, Treatment A + Treatment B: TAK-279 50 mg + Erythromycin 500 mg Erythromycin Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg, on Day 5 and erythromycin 500 mg orally thrice daily (TID) on Day 1 through Day 10 of Period 2 in Part 1 of the study. Part 2, Treatment C + Treatment D: TAK-279 50 mg + Phenytoin 100 mg Phenytoin Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 14 and phenytoin 100 mg orally TID on Day 1 through Day 18 of Period 2 in Part 2 of the study. Part 3, Treatment E + Treatment F: TAK-279 50 mg + Efavirenz 600 mg Efavirenz Participants will receive single oral dose of TAK-279 50 mg, on Day 1 of Period 1. Following Period 1 participants will receive single oral dose of TAK-279 50 mg on Day 11 and efavirenz 600 mg orally once daily (QD) on Day 1 through Day 15 of Period 2 in Part 3 of the study.
- Primary Outcome Measures
Name Time Method Parts 1, 2, and 3: Cmax: Maximum Observed Plasma Concentration for TAK-279 Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days) Parts 1, 2, and 3: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-279 Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days) Parts 1, 2, and 3: AUC∞: Area Under the Plasma Concentration-time Curve from Time 0 to Infinity for TAK-279 Predose and at multiple timepoints post dose from Day 1 period 1 (length= 6 days) to period 2 Day 11 in Part 1 (length= 11 days), up to period 2 Day 19 in Part 2 (length= 19 days) and up to period 2 Day 16 in Part 3 (length= 16 days)
- Secondary Outcome Measures
Name Time Method Parts 1, 2, and 3: Number of Participants with Abnormal Laboratory Values From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3 Abnormal laboratory investigation will include hematology, chemistry, and urinalysis analysis as determined by the investigator.
Parts 1, 2, and 3: Number of Participants with Treatment-emergent Adverse Events (TEAEs) From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3 Parts 1, 2, and 3: Number of Participants with Abnormal Vital Signs From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3 Abnormal vital sign assessment will include assessments of systolic and diastolic blood pressure, pulse rate, respiration rate, body temperature as determined by the investigator.
Parts 1, 2, and 3: Number of Participants with Abnormal Electrocardiogram Findings From Day 1 of period 1 through period 2 Day 11 (up to approximately 65 days) in Part 1, up to period 2 Day 19 (up to approximately 73 days) in Part 2 and up to period 2 Day 16 (up to approximately 70 days) in Part 3 Abnormal 12-lead ECG findings will include heart rate and measures PR, QRS, QT and QTcF intervals. 12-lead ECG recordings were obtained after the participants have rested for at least 5 minutes in supine position as determined by the investigator.
Trial Locations
- Locations (1)
Celerion - Tempe, AZ Site
🇺🇸Tempe, Arizona, United States