The aim of this study is to understand how TAK-906 tablets and capsules are processed by the body in healthy adults under fasting conditions and also how TAK-906 tablets are processed by the body when taken with a high fat high calorie breakfast compared to fasting. This study will require participants to stay at the clinical research unit for about 3 weeks to be monitored after receiving TAK-906.
The drug being tested in this study is called TAK-906. This study will compare the pharmacokinetics (PK) of single oral dose of 50 mg tablet (test \[Treatment B\]) relative to single oral dose of 50 mg capsule (reference \[Treatment A\]) under fasted conditions. The study will also explore the effect of food on 50 mg tablet formulation (Treatment C: high-fat/high-calorie meal) on TAK-906 PK following tablet administration relative to the fasted state (Treatment B). The study will enroll approximately 24 participants. Participants will be randomly assigned to 1 of the 2 treatment sequences. This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 60 days. Participants will be followed up for up to 14 days after the last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Celerion
Tempe, Arizona, United States
Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet Relative to TAK-906 Capsule Administration Under Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Number of Participants Reporting one or More Adverse Events (AEs)
Time frame: Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)
Number of Participants Reporting one or More Serious Adverse Events (SAEs)
Time frame: Baseline up to 14 days after the last dose of study drug in Period 5 (Day 31)
Geometric Mean Ratio of AUClast: Area Under the Concentration-time Curve From Time 0 to the Last Quantifiable Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Geometric Mean Ratio of AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
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Geometric Mean Ratio of Cmax: Maximum Observed Plasma Concentration Following TAK-906 Tablet in fed state Relative to TAK-906 Tablet in Fasted State
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC%extrap: Percent of AUCinf Extrapolated After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Tmax: Time to Reach Maximum Plasma Concentration After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Tlag: Lag Time to First Quantifiable Concentration After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Kel: Apparent Terminal First Order Elimination Rate Constant After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
CL/F: Apparent Plasma Clearance After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Vz/F: Apparent Volume of Distribution During the Terminal Elimination Phase After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
t½: Terminal Half-life After Single Dose of TAK-906
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose