ID

35784

Descripción

A Study to Assess the Relative Bioavailability and to Assess the Effect of Food on the Bioavailability of a TAK-648 Tablet in Healthy Participants; ODM derived from: https://clinicaltrials.gov/show/NCT02480439

Link

https://clinicaltrials.gov/show/NCT02480439

Palabras clave

Versiones (1)
  1. 22/3/19 22/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Diabetes Mellitus, Type 2 NCT02480439

Inglés

Eligibility Diabetes Mellitus, Type 2 NCT02480439

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. healthy male or female aged 18 to 55 years, inclusive, at the time of informed consent and first study medication dose.
Descripción

Healthy Volunteers | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0001779
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.
Descripción

Body Weight | Body mass index

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
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.
Descripción

Systolic Pressure | Diastolic blood pressure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0871470
UMLS CUI [2]
C0428883
4. has a calculated creatinine clearance >60 milliliter per minute (ml/min) at screening and check-in (day -1) of period 1.
Descripción

Estimation of creatinine clearance by Cockcroft-Gault formula

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2711451
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.
Descripción

Gender Sexually active Contraceptive methods | Male sterilization Absent | Partner Childbearing Potential

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C0024559
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0682323
UMLS CUI [3,2]
C3831118
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.
Descripción

Childbearing Potential Sexually active Contraceptive methods | Partner Male sterilization Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0241028
UMLS CUI [1,3]
C0700589
UMLS CUI [2,1]
C0682323
UMLS CUI [2,2]
C0024559
UMLS CUI [2,3]
C0332197
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. has received any investigational compound within 30 days prior to the first dose of study medication.
Descripción

Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
2. has received tak-648 in a previous clinical study or as a therapeutic agent.
Descripción

Phosphodiesterase 4 Inhibitors | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2936609
UMLS CUI [2]
C3846158
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.
Descripción

Family member | Study Site Employee

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0086282
UMLS CUI [2,1]
C2825164
UMLS CUI [2,2]
C0599987
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.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205318
UMLS CUI [2,3]
C2348568
UMLS CUI [2,4]
C1444641
UMLS CUI [3,1]
C0262926
UMLS CUI [3,2]
C4049986
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0205318
UMLS CUI [4,3]
C4049986
UMLS CUI [4,4]
C2348568
UMLS CUI [5,1]
C0262926
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0683954
UMLS CUI [6,1]
C3843040
UMLS CUI [6,2]
C0205318
UMLS CUI [6,3]
C0521102
UMLS CUI [6,4]
C0683954
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.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0017178
UMLS CUI [2]
C0746782
UMLS CUI [3]
C0746779
UMLS CUI [4,1]
C0027497
UMLS CUI [4,2]
C0205267
UMLS CUI [5]
C0152165
UMLS CUI [6]
C0232598
UMLS CUI [7]
C0401157
UMLS CUI [8]
C0743188
UMLS CUI [9]
C0401151
UMLS CUI [10]
C0239181
UMLS CUI [11,1]
C0017178
UMLS CUI [11,2]
C4054723
UMLS CUI [11,3]
C0678745
6. has diagnosis of major depression, bipolar disorder, or anxiety disorders, or has received any medication to treat any psychological disorders within 1 year.
Descripción

Major Depressive Disorder | Bipolar Disorder | Anxiety Disorders | Pharmacotherapy Mental disorders

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1269683
UMLS CUI [2]
C0005586
UMLS CUI [3]
C0003469
UMLS CUI [4,1]
C0013216
UMLS CUI [4,2]
C0004936
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.
Descripción

At risk for suicide Columbia suicide severity rating scale | Suicide attempt

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0563664
UMLS CUI [1,2]
C3888485
UMLS CUI [2]
C0038663
8. has known hypersensitivity to any component of the formulation of tak-648, or to a phosphodiesterase type 4 (pde4) inhibitor (example, roflumilast).
Descripción

Other Coding | Hypersensitivity Phosphodiesterase 4 Inhibitors | Hypersensitivity Roflumilast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C2936609
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0965618
9. has taken any excluded medication, supplements, or food products during the time periods listed in the prohibited medications table.
Descripción

Pharmaceutical Preparations Excluded | Supplements Excluded | Food product Excluded

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0332196
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0332196
UMLS CUI [3,1]
C0681562
UMLS CUI [3,2]
C0332196
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).
Descripción

Laboratory test result abnormal Suggestive of Primary disorder | Alanine aminotransferase increased | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0438215
UMLS CUI [1,2]
C0332299
UMLS CUI [1,3]
C0277554
UMLS CUI [2]
C0151905
UMLS CUI [3]
C0151904
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Similar models

Eligibility Diabetes Mellitus, Type 2 NCT02480439

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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