The purpose of this study is to evaluate the effect of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of orally administered TAK-906.
The drug being tested in this study is called TAK-906. TAK-906 is being tested in healthy participants to evaluate the effect of a PPI esomeprazole on the PK of TAK-906. The study will enroll approximately 12 participants. Participants will be assigned to the following treatment sequence: • TAK-906 25 mg; Esomeprazole 40 mg + TAK-906 25 mg All participants will be given an oral dose of TAK-906 and Esomeprazole. This single center trial will be conducted in the United States. The overall duration to participate in this study is 52 days. Participants will make visit to the clinic during Period 1 and Period 2 in addition to approximately 10 to 14 days after receiving their last dose of TAK-906 for a follow up assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
12
TAK-906 capsules.
Esomeprazole capsules.
Celerion
Tempe, Arizona, United States
Cmax: Maximum Observed Plasma Concentration for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906
Time frame: TAK-906 25 mg: Day 1 pre-dose and at multiple time points (up to 48 hours) post-TAK-906 dose; Esomeprazole 40 mg and TAK-906 25 mg: Day 4 pre-dose and at multiple time points (up to 48 hours) post- TAK-906 dose
Number of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Grade 3 or Higher TEAEs
A severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL); Grade 3 scales as severe(severe or medically significant but not immediately life threatening hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4 scales as life-threatening consequences, urgent intervention indicated, and Grade 5 scales as death related to AE.
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
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Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG)
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)
Number of Participants With Clinically Significant Change From Baseline Clinical Laboratory Values
Time frame: Baseline up to 14 days after last dose of TAK-906 in Study Period 2 (Day 23)