ID

40990

Beschreibung

TMC647055HPC1001 - First-in-human Trial to Examine Safety, Tolerability and Pharmacokinetics (How the Drug is Absorbed Into the Bloodstream) of Increasing Single Oral Doses and of Increasing Repeated Oral Doses of TMC647055 in Healthy Volunteers and in Hepatitis C Virus Infected Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01202825

Link

https://clinicaltrials.gov/show/NCT01202825

Stichworte

Versionen (1)
  1. 08.06.20 08.06.20 -
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See clinicaltrials.gov

Hochgeladen am

8. Juni 2020

DOI

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Creative Commons BY 4.0
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Eligibility Hepatitis C NCT01202825

Englisch

Eligibility Hepatitis C NCT01202825

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, triplicate electrocardiogram and vital signs, performed at screening, have a body mass index (bmi, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to selection
Beschreibung

Healthy Volunteers | Physical Examination | Medical History | Laboratory Procedures | Electrocardiogram Triplicate | Vital signs | Body mass index | Non-smoker

Datentyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0031809
UMLS CUI [3]
C0262926
UMLS CUI [4]
C0022885
UMLS CUI [5,1]
C0013798
UMLS CUI [5,2]
C0205174
UMLS CUI [6]
C0518766
UMLS CUI [7]
C1305855
UMLS CUI [8]
C0337672
chronic hepatitis-c infected patients should have documented chronic genotype 1a or 1b hcv infection, otherwise no clinically relevant currently active disease and a bmi of 18.0 to 35.0 kg/m2, extremes included
Beschreibung

Chronic Hepatitis C Genotype | Absence Comorbidity Relevance Clinical | Body mass index

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0524910
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0009488
UMLS CUI [2,3]
C2347946
UMLS CUI [2,4]
C0205210
UMLS CUI [3]
C1305855
women must be postmenopausal for at least 2 years, and/or be surgically sterile.
Beschreibung

Postmenopausal state | Female Sterilization

Datentyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
all participants with a drug allergy such as, but not limited to, sulfonamides and penicillins, or with a drug allergy as witnessed in previous trials with experimental drugs
Beschreibung

Drug Allergy | Allergy to sulfonamides | Allergy to penicillin | Hypersensitivity Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013182
UMLS CUI [2]
C0038757
UMLS CUI [3]
C0030824
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0013230
use of concomitant medication, including over-the-counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen or hormone replacement therapy or for chronic hepatitis-c infected patients products that are not cyp3a4 inhibitors or inducers and stable use of methadone, in a period of 14 days before the first trial medication administration
Beschreibung

Pharmaceutical Preparations Additional | Drugs, Non-Prescription | Herbal medicine (product) | Dietary Supplements | Exception Acetaminophen | Exception Ibuprofen | Exception Hormone replacement therapy | Exception Products Chronic Hepatitis C | CYP3A4 Inhibitors Excluded | CYP3A4 Inducers Excluded | Methadone Stable Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1524062
UMLS CUI [2]
C0013231
UMLS CUI [3]
C2240391
UMLS CUI [4]
C0242295
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0000970
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0020740
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0282402
UMLS CUI [8,1]
C1705847
UMLS CUI [8,2]
C1254351
UMLS CUI [8,3]
C0524910
UMLS CUI [9,1]
C3850053
UMLS CUI [9,2]
C0332196
UMLS CUI [10,1]
C3850041
UMLS CUI [10,2]
C0332196
UMLS CUI [11,1]
C0025605
UMLS CUI [11,2]
C0205360
UMLS CUI [11,3]
C0332196
any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements
Beschreibung

Condition At risk Clinical Trial | Condition At risk Patient Health | Condition Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0030705
UMLS CUI [2,4]
C0018684
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C1292733
UMLS CUI [3,3]
C0525058
history or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures
Beschreibung

Alcohol consumption At risk Patient safety | Alcohol consumption At risk Protocol Compliance | Suspicion Alcohol consumption | Barbiturates | Suspicion Barbiturates | Amphetamines | Suspicion Amphetamines | Recreational Drugs | Suspicion Recreational Drugs | Narcotic Drugs | Suspicion Narcotic Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C1113679
UMLS CUI [2,1]
C0001948
UMLS CUI [2,2]
C1444641
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0242114
UMLS CUI [3,2]
C0001948
UMLS CUI [4]
C0004745
UMLS CUI [5,1]
C0242114
UMLS CUI [5,2]
C0004745
UMLS CUI [6]
C0002667
UMLS CUI [7,1]
C0242114
UMLS CUI [7,2]
C0002667
UMLS CUI [8]
C0242508
UMLS CUI [9,1]
C0242114
UMLS CUI [9,2]
C0242508
UMLS CUI [10]
C0237425
UMLS CUI [11,1]
C0242114
UMLS CUI [11,2]
C0237425
participation in an investigational drug trial or having received an investigational vaccine within 30 days prior to the first intake of tmc647055 or placebo.
Beschreibung

Study Subject Participation Status | Clinical Trial | Investigational New Drug | INVESTIGATIONAL VACCINES

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3]
C0013230
UMLS CUI [4]
C1875384
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Ähnliche Modelle

Eligibility Hepatitis C NCT01202825

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Healthy Volunteers | Physical Examination | Medical History | Laboratory Procedures | Electrocardiogram Triplicate | Vital signs | Body mass index | Non-smoker
Item
healthy volunteers should be healthy on the basis of physical examination, medical history, laboratory tests, triplicate electrocardiogram and vital signs, performed at screening, have a body mass index (bmi, weight in kg divided by the square of height in meters) of 18.0 to 30.0 kg/m2, extremes included and be non-smoking for at least 3 months prior to selection
boolean
C1708335 (UMLS CUI [1])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C0013798 (UMLS CUI [5,1])
C0205174 (UMLS CUI [5,2])
C0518766 (UMLS CUI [6])
C1305855 (UMLS CUI [7])
C0337672 (UMLS CUI [8])
Chronic Hepatitis C Genotype | Absence Comorbidity Relevance Clinical | Body mass index
Item
chronic hepatitis-c infected patients should have documented chronic genotype 1a or 1b hcv infection, otherwise no clinically relevant currently active disease and a bmi of 18.0 to 35.0 kg/m2, extremes included
boolean
C0524910 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0009488 (UMLS CUI [2,2])
C2347946 (UMLS CUI [2,3])
C0205210 (UMLS CUI [2,4])
C1305855 (UMLS CUI [3])
Postmenopausal state | Female Sterilization
Item
women must be postmenopausal for at least 2 years, and/or be surgically sterile.
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Drug Allergy | Allergy to sulfonamides | Allergy to penicillin | Hypersensitivity Investigational New Drugs
Item
all participants with a drug allergy such as, but not limited to, sulfonamides and penicillins, or with a drug allergy as witnessed in previous trials with experimental drugs
boolean
C0013182 (UMLS CUI [1])
C0038757 (UMLS CUI [2])
C0030824 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0013230 (UMLS CUI [4,2])
Pharmaceutical Preparations Additional | Drugs, Non-Prescription | Herbal medicine (product) | Dietary Supplements | Exception Acetaminophen | Exception Ibuprofen | Exception Hormone replacement therapy | Exception Products Chronic Hepatitis C | CYP3A4 Inhibitors Excluded | CYP3A4 Inducers Excluded | Methadone Stable Excluded
Item
use of concomitant medication, including over-the-counter products, herbal medication and dietary supplements, except for paracetamol (acetaminophen) or ibuprofen or hormone replacement therapy or for chronic hepatitis-c infected patients products that are not cyp3a4 inhibitors or inducers and stable use of methadone, in a period of 14 days before the first trial medication administration
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0013231 (UMLS CUI [2])
C2240391 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0000970 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0020740 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0282402 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C1254351 (UMLS CUI [8,2])
C0524910 (UMLS CUI [8,3])
C3850053 (UMLS CUI [9,1])
C0332196 (UMLS CUI [9,2])
C3850041 (UMLS CUI [10,1])
C0332196 (UMLS CUI [10,2])
C0025605 (UMLS CUI [11,1])
C0205360 (UMLS CUI [11,2])
C0332196 (UMLS CUI [11,3])
Condition At risk Clinical Trial | Condition At risk Patient Health | Condition Preventing Protocol Compliance
Item
any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting or performing study requirements
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0030705 (UMLS CUI [2,3])
C0018684 (UMLS CUI [2,4])
C0348080 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Alcohol consumption At risk Patient safety | Alcohol consumption At risk Protocol Compliance | Suspicion Alcohol consumption | Barbiturates | Suspicion Barbiturates | Amphetamines | Suspicion Amphetamines | Recreational Drugs | Suspicion Recreational Drugs | Narcotic Drugs | Suspicion Narcotic Drugs
Item
history or suspicion of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the trial procedures
boolean
C0001948 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0001948 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0242114 (UMLS CUI [3,1])
C0001948 (UMLS CUI [3,2])
C0004745 (UMLS CUI [4])
C0242114 (UMLS CUI [5,1])
C0004745 (UMLS CUI [5,2])
C0002667 (UMLS CUI [6])
C0242114 (UMLS CUI [7,1])
C0002667 (UMLS CUI [7,2])
C0242508 (UMLS CUI [8])
C0242114 (UMLS CUI [9,1])
C0242508 (UMLS CUI [9,2])
C0237425 (UMLS CUI [10])
C0242114 (UMLS CUI [11,1])
C0237425 (UMLS CUI [11,2])
Study Subject Participation Status | Clinical Trial | Investigational New Drug | INVESTIGATIONAL VACCINES
Item
participation in an investigational drug trial or having received an investigational vaccine within 30 days prior to the first intake of tmc647055 or placebo.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
C1875384 (UMLS CUI [4])
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