Healthy Volunteers | Age
Item
1. healthy male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
boolean
C1708335 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Body Weight | Body mass index
Item
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.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Systolic Pressure | Diastolic blood pressure
Item
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.
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula
Item
4. has a calculated creatinine clearance >60 milliliter per minute (ml/min) at screening and check-in (day -1) of period 1.
boolean
C2711451 (UMLS CUI [1])
Gender Sexually active Contraceptive methods | Male sterilization Absent | Partner Childbearing Potential
Item
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.
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0024559 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C3831118 (UMLS CUI [3,2])
Childbearing Potential Sexually active Contraceptive methods | Partner Male sterilization Absent
Item
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.
boolean
C3831118 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0682323 (UMLS CUI [2,1])
C0024559 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Investigational New Drugs
Item
1. has received any investigational compound within 30 days prior to the first dose of study medication.
boolean
C0013230 (UMLS CUI [1])
Phosphodiesterase 4 Inhibitors | Other Coding
Item
2. has received tak-648 in a previous clinical study or as a therapeutic agent.
boolean
C2936609 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Family member | Study Site Employee
Item
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.
boolean
C0086282 (UMLS CUI [1])
C2825164 (UMLS CUI [2,1])
C0599987 (UMLS CUI [2,2])
Medical History Study Subject Participation Status At risk | Medical condition Uncontrolled Study Subject Participation Status At risk | Medical History Impact Study Subject Participation Status | Medical condition Uncontrolled Impact Study Subject Participation Status | Medical History Interferes with Research results | Medical condition Uncontrolled Interferes with Research results
Item
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.
boolean
C0262926 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C1444641 (UMLS CUI [2,4])
C0262926 (UMLS CUI [3,1])
C4049986 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C3843040 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C4049986 (UMLS CUI [4,3])
C2348568 (UMLS CUI [4,4])
C0262926 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])
C3843040 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0521102 (UMLS CUI [6,3])
C0683954 (UMLS CUI [6,4])
Gastrointestinal Diseases | Persistent nausea | Chronic nausea | Nausea Intermittent | Persistent vomiting | Chronic vomiting | Intermittent vomiting | Diarrhea persistent | Chronic diarrhea | Intermittent diarrhea | Gastrointestinal Disease Influence Drug absorption
Item
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.
boolean
C0017178 (UMLS CUI [1])
C0746782 (UMLS CUI [2])
C0746779 (UMLS CUI [3])
C0027497 (UMLS CUI [4,1])
C0205267 (UMLS CUI [4,2])
C0152165 (UMLS CUI [5])
C0232598 (UMLS CUI [6])
C0401157 (UMLS CUI [7])
C0743188 (UMLS CUI [8])
C0401151 (UMLS CUI [9])
C0239181 (UMLS CUI [10])
C0017178 (UMLS CUI [11,1])
C4054723 (UMLS CUI [11,2])
C0678745 (UMLS CUI [11,3])
Major Depressive Disorder | Bipolar Disorder | Anxiety Disorders | Pharmacotherapy Mental disorders
Item
6. has diagnosis of major depression, bipolar disorder, or anxiety disorders, or has received any medication to treat any psychological disorders within 1 year.
boolean
C1269683 (UMLS CUI [1])
C0005586 (UMLS CUI [2])
C0003469 (UMLS CUI [3])
C0013216 (UMLS CUI [4,1])
C0004936 (UMLS CUI [4,2])
At risk for suicide Columbia suicide severity rating scale | Suicide attempt
Item
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.
boolean
C0563664 (UMLS CUI [1,1])
C3888485 (UMLS CUI [1,2])
C0038663 (UMLS CUI [2])
Other Coding | Hypersensitivity Phosphodiesterase 4 Inhibitors | Hypersensitivity Roflumilast
Item
8. has known hypersensitivity to any component of the formulation of tak-648, or to a phosphodiesterase type 4 (pde4) inhibitor (example, roflumilast).
boolean
C3846158 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C2936609 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0965618 (UMLS CUI [3,2])
Pharmaceutical Preparations Excluded | Supplements Excluded | Food product Excluded
Item
9. has taken any excluded medication, supplements, or food products during the time periods listed in the prohibited medications table.
boolean
C0013227 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0242295 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0681562 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Laboratory test result abnormal Suggestive of Primary disorder | Alanine aminotransferase increased | Aspartate aminotransferase increased
Item
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).
boolean
C0438215 (UMLS CUI [1,1])
C0332299 (UMLS CUI [1,2])
C0277554 (UMLS CUI [1,3])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])