ID

29699

Beskrivning

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK3281 in Healthy and Hepatitis C Infected Male Patients (MK-3281-002)(TERMINATED); ODM derived from: https://clinicaltrials.gov/show/NCT00635804

Länk

https://clinicaltrials.gov/show/NCT00635804

Nyckelord

Versioner (1)
  1. 2018-04-13 2018-04-13 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

13 april 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Hepatitis C NCT00635804

Engelsk

Eligibility Hepatitis C NCT00635804

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Beskrivning

Good health | Medical History | Physical Examination | Vital signs | Laboratory Tests Safety

Datatyp

boolean

Alias
UMLS CUI [1]
C3813622
UMLS CUI [2]
C0262926
UMLS CUI [3]
C0031809
UMLS CUI [4]
C0518766
UMLS CUI [5,1]
C0022885
UMLS CUI [5,2]
C0036043
subject has no clinically significant abnormality on electrocardiogram (ecg) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
Beskrivning

ECG normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0522054
subjects with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
Beskrivning

Partner Childbearing Potential | Study Subject Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0682323
UMLS CUI [1,2]
C3831118
UMLS CUI [2,1]
C0681850
UMLS CUI [2,2]
C0700589
patient has a clinical diagnosis of chronic hcv infection.
Beskrivning

Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C0524910
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has a history of stroke, chronic seizures, or major neurological disorder
Beskrivning

Cerebrovascular accident | Seizures chronic | Nervous system disorder Major

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2,1]
C0036572
UMLS CUI [2,2]
C0205191
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C0205164
subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
Beskrivning

Endocrine System Diseases | Gastrointestinal Diseases | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system

Datatyp

boolean

Alias
UMLS CUI [1]
C0014130
UMLS CUI [2]
C0017178
UMLS CUI [3]
C0007222
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0021053
UMLS CUI [6]
C0022658
UMLS CUI [7]
C0035204
UMLS CUI [8]
C0080276
subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
Beskrivning

Neoplastic disease | Leukemia | Lymphoma | Melanoma malignant | Myeloproliferative disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2]
C0023418
UMLS CUI [3]
C0024299
UMLS CUI [4,1]
C0025202
UMLS CUI [4,2]
C0205282
UMLS CUI [5]
C0027022
subject has positive hepatitis b surface antigen (or other evidence of active hepatitis b infection) at the prescreening (study) visit
Beskrivning

Hepatitis B surface antigen positive | Hepatitis B

Datatyp

boolean

Alias
UMLS CUI [1]
C0149709
UMLS CUI [2]
C0019163
for healthy panel, subject has evidence of chronic hepatitis c virus infection at the prescreening (study) visit
Beskrivning

Group Healthy | Hepatitis C, Chronic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0441833
UMLS CUI [1,2]
C3898900
UMLS CUI [2]
C0524910
subject has a history of documented hivinfection
Beskrivning

HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
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Similar models

Eligibility Hepatitis C NCT00635804

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Good health | Medical History | Physical Examination | Vital signs | Laboratory Tests Safety
Item
subject is judged to be in good/stable health based on medical history, physical examination, vital signs, and laboratory safety tests performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
boolean
C3813622 (UMLS CUI [1])
C0262926 (UMLS CUI [2])
C0031809 (UMLS CUI [3])
C0518766 (UMLS CUI [4])
C0022885 (UMLS CUI [5,1])
C0036043 (UMLS CUI [5,2])
ECG normal
Item
subject has no clinically significant abnormality on electrocardiogram (ecg) performed at the prestudy (screening) visit and/or prior to administration of the initial dose of study drug
boolean
C0522054 (UMLS CUI [1])
Partner Childbearing Potential | Study Subject Contraceptive methods
Item
subjects with female partner(s) of childbearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
boolean
C0682323 (UMLS CUI [1,1])
C3831118 (UMLS CUI [1,2])
C0681850 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Hepatitis C, Chronic
Item
patient has a clinical diagnosis of chronic hcv infection.
boolean
C0524910 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cerebrovascular accident | Seizures chronic | Nervous system disorder Major
Item
subject has a history of stroke, chronic seizures, or major neurological disorder
boolean
C0038454 (UMLS CUI [1])
C0036572 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0027765 (UMLS CUI [3,1])
C0205164 (UMLS CUI [3,2])
Endocrine System Diseases | Gastrointestinal Diseases | Cardiovascular Diseases | Hematological Disease | Immune System Diseases | Kidney Diseases | Respiration Disorders | Disorder of the genitourinary system
Item
subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, immunological, renal, respiratory, or genitourinary abnormalities or diseases
boolean
C0014130 (UMLS CUI [1])
C0017178 (UMLS CUI [2])
C0007222 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0021053 (UMLS CUI [5])
C0022658 (UMLS CUI [6])
C0035204 (UMLS CUI [7])
C0080276 (UMLS CUI [8])
Neoplastic disease | Leukemia | Lymphoma | Melanoma malignant | Myeloproliferative disease
Item
subject has a history of neoplastic disease (including leukemia, lymphoma, malignant melanoma), or myeloproliferative disease, regardless of the time since treatment
boolean
C1882062 (UMLS CUI [1])
C0023418 (UMLS CUI [2])
C0024299 (UMLS CUI [3])
C0025202 (UMLS CUI [4,1])
C0205282 (UMLS CUI [4,2])
C0027022 (UMLS CUI [5])
Hepatitis B surface antigen positive | Hepatitis B
Item
subject has positive hepatitis b surface antigen (or other evidence of active hepatitis b infection) at the prescreening (study) visit
boolean
C0149709 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
Group Healthy | Hepatitis C, Chronic
Item
for healthy panel, subject has evidence of chronic hepatitis c virus infection at the prescreening (study) visit
boolean
C0441833 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0524910 (UMLS CUI [2])
HIV Infection
Item
subject has a history of documented hivinfection
boolean
C0019693 (UMLS CUI [1])
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