The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.
The drug being tested in this study is called TAK-935. The study will look at the relative BA of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants. The study will enroll approximately 9 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 3 treatment sequences: * TAK-935 (300 mg Tablets Fed + 300 mg Tablets Fasted + 300 mg Solution Fasted) * TAK-935 (300 mg Tablets Fasted + 300 mg Solution Fasted + 300 mg Tablets Fed) * TAK-935 (300 mg Solution Fasted + 300 mg Tablets Fed + 300 mg Tablets Fasted) Administration of each dose will be separated by a washout period of at least 3 days. Participants will be asked to take single dose of TAK-935 tablet or oral solution on Day 1 of each Intervention Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 39 days. Participants will remain confined to the clinic from Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by telephone 30 days after last dose of TAK-935 for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
9
Tablets
Oral solution
Unnamed facility
Glendale, California, United States
Cmax: Maximum Observed Plasma Concentration for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUCt: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to 30 days after last dose of study drug (Day 39)
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose
Time frame: Baseline up to Day 11
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose.
Time frame: Baseline up to Day 11
Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Post Dose
Time frame: Baseline up to Day 11
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