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.
1. Healthy male or female aged 18 to 55 years, inclusive, at the time of informed
consent and first study medication dose.
2. Weighs at least 50 kilogram (kg) (110 pounds [lbs]) and has a body mass index (BMI)
from 18.0 to 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
3. Has systolic blood pressure greater than (>) 90 and less than or equal to (<=) 150
millimeter of mercury (mmHg) and diastolic blood pressure >60 and <=90 mm Hg at
Screening and at Check-in (Day -1) of Period 1. If out of range, may be repeated once
for eligibility determination within a maximum of 5 minutes.
4. Has a calculated creatinine clearance >60 milliliter per minute (mL/min) at Screening
and Check-in (Day -1) of Period 1.
5. Male participant who is nonsterilized and sexually active with a female partner of
childbearing potential agrees to use adequate contraception from signing of informed
consent throughout the duration of the study and for 12 weeks after last dose.
6. Female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from
signing of informed consent and throughout the duration of the study and for 12 weeks
after the last dose.
1. Has received any investigational compound within 30 days prior to the first dose of
2. Has received TAK-648 in a previous clinical study or as a therapeutic agent.
3. Is an immediate family member, study site employee, or is in a dependent relationship
with a study site employee who is involved in the conduct of this study (example,
spouse, parent, child, sibling) or may consent under duress.
4. Has any significant medical histories or currently uncontrolled clinical conditions,
which may render it unsafe for participant to participate in the study, may impact
the ability of the participant to participate in the study, or may potentially
confound the study results.
5. Has a history of significant gastrointestinal (GI) disorders manifested with
persistent, chronic, or intermittent nausea, vomiting, or diarrhea, or has a current
or recent (within 6 months) GI disease that would influence the absorption of drugs.
6. Has diagnosis of major depression, bipolar disorder, or anxiety disorders, or has
received any medication to treat any psychological disorders within 1 year.
7. Has a risk of suicide according to the investigator's clinical judgment per
Columbia-Suicide Severity Rating Scale (C-SSRS) at screening or has made a suicide
attempt in the past 6 months prior to screening.
8. Has known hypersensitivity to any component of the formulation of TAK-648, or to a
phosphodiesterase type 4 (PDE4) inhibitor (example, roflumilast).
9. Has taken any excluded medication, supplements, or food products during the time
periods listed in the Prohibited Medications table.
10. Has abnormal Screening or Check-in (Day -1) of Period 1 laboratory values that
suggest a clinically significant underlying disease or participant has the following
laboratory abnormalities: Alanine aminotransferase (ALT) and/or aspartate
aminotransferase (AST) >2.5* upper limit of normal (ULN).