The purpose of this study is to assess the relative bioavailability of a TAK-648 tablet compared with a TAK-648 oral solution, and to assess the effect of food on the bioavailability of a TAK-648 tablet in healthy participants.
This study will assess the relative Bioavailability (BA) of TAK-648 tablet compared with that of TAK-648 solution and the effect of food on the BA of the TAK-648 tablet. The study will enroll approximately 24 healthy participants. Participants will be randomly assigned to one of the three treatment sequences: * TAK-648 tablet in fed state, followed by TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state * TAK-648 tablet in fasted state, followed by TAK-648 oral solution in fasted state, followed by TAK-648 tablet in fed state * TAK-648 oral solution in fasted state, TAK-648 tablet in fed state, TAK-648 tablet in fasted state The dosing in a period and the subsequent period will be separated by a minimum 7-day washout interval. Participants will be asked to take single dose of TAK-648 tablet or oral solution on Day 1 of each period. This single-center trial will be conducted in the United States. Participants will make 4 visits to the clinic including three 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Tak-648 tablet
TAK-648 oral solution
Unnamed facility
Austin, Texas, United States
Cmax: Maximum Observed Plasma Concentration for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-648
Time frame: Day 1 pre-dose and multiple timepoints post-dose (Up to 72 hours) in each Period
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Time frame: First dose of study drug to 30 days after the last dose of study drug (Up to Day 47)
Percentage of Participants With Markedly Abnormal Laboratory Values at Least Once Post-dose
Time frame: First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)
Percentage of Participants With Markedly Abnormal Vital Sign Values at Least Once Post-dose
Vital signs included body temperature (oral), sitting blood pressure (after 5 minutes resting), respiration rate and pulse (beats per minute \[bpm\]).
Time frame: First dose of study drug to 7 days after the last dose of study drug (Up to Day 24)
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