ID

33962

Beschreibung

Study ID: 101682 Clinical Study ID: B2E101682 Study Title: A randomised, double-blind, placebo-controlled, parallel group study to examine the safety, tolerability, and pharmacokinetics of repeat inhaled doses of GSK159797 in healthy subjects. Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: milveterol Study Indication: Pulmonary Disease, Chronic Obstructive This form contains Eligibility criteria. It has to be filled in at screening procedure (session number 1).

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  1. 09.01.19 09.01.19 -
  2. 09.01.19 09.01.19 -
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GlaxoSmithKline

Hochgeladen am

9. Januar 2019

DOI

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Safety, tolerability and pharmacokinetics of repeat inhaled doses of milveterol in healthy subjects (Study ID: 101682)

Englisch

Eligibility criteria

1 Formulare  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beschreibung

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beschreibung

Subject number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Eligibility determination
Beschreibung

Eligibility determination

Alias
UMLS CUI-1
C0013893
Did the subject meet all entry criteria (i.e., all "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
Beschreibung

Eligibility determination

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy adult male aged between 18 - 55 years
Beschreibung

Healthy adult male aged between 18- 55 years

Datentyp

boolean

Alias
UMLS CUI [1]
C3898900
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
Body mass index (BMI) within the range 18.5–29.9 kg/m2
Beschreibung

Body mass index (BMI)

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Forced expiratory volume in 1 second (FEV1) ≥80% predicted and a FEV1/Forced Vital Capacity (FVC) ratio ≥0.7
Beschreibung

Forced exspiratory volume in 1 second (FEV1) and FEV1/Forced Vital Capacity (FVC) ratio

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0024109
UMLS CUI [1,2]
C0024119
UMLS CUI [1,3]
C0849974
UMLS CUI [2,1]
C0024109
UMLS CUI [2,2]
C0024119
UMLS CUI [2,3]
C0429745
A signed and dated written informed consent was obtained from the subject
Beschreibung

Informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
The subject was able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions
Beschreibung

Comprehension of and Corresponding to protocol requirements, instructions and protocol-stated restrictions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [2,1]
C2348563
UMLS CUI [2,2]
C0525058
Subjects who were current non-smokers who had not used any tobacco products in the 6-month period preceding the screening visit and had a pack history of ≤10 pack years (pack history = (number of cigarettes per day/20) x number of years smoked).
Beschreibung

tobacco use

Datentyp

boolean

Alias
UMLS CUI [1]
C0543414
Exclusion criteria
Beschreibung

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead or Holter)
Beschreibung

clinically relevant abnormality identified at the screening medical assessment

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1704258
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0031809
UMLS CUI [2,1]
C1704258
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C1704258
UMLS CUI [3,2]
C2985739
UMLS CUI [3,3]
C0022885
UMLS CUI [4,1]
C1704258
UMLS CUI [4,2]
C2985739
UMLS CUI [4,3]
C1623258
A history of breathing problems (eg history of asthmatic symptoms)
Beschreibung

History of breathing problems

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0035203
UMLS CUI [1,3]
C1254481
A mean QTc(B) value at screening >430 msec, any of the 3 screening ECGs not within 10% of the mean, a mean PR interval outside the range 120 - 210 msec or an ECG that was not suitable for QT measurements (eg poorly defined termination of the T wave)
Beschreibung

Abnormal screening ECG

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0220908
UMLS CUI [1,3]
C0489625
UMLS CUI [1,4]
C0444504
UMLS CUI [2,1]
C1623258
UMLS CUI [2,2]
C0220908
UMLS CUI [2,3]
C0429087
UMLS CUI [2,4]
C0444504
UMLS CUI [3,1]
C1623258
UMLS CUI [3,2]
C0220908
UMLS CUI [3,3]
C0577807
UMLS CUI [3,4]
C3827727
A history of elevated supine blood pressure (BP) or a mean supine BP equal to or higher than 150/90 millimetres of mercury (mm Hg) at screening
Beschreibung

Supine blood pressure in medical history and at screening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0038846
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0005823
UMLS CUI [2,2]
C0038846
UMLS CUI [2,3]
C0220908
A mean heart rate (HR) outside the range 40 - 90 beats per minute (beats/min) at screening
Beschreibung

Mean heart rate at screening

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C0444504
UMLS CUI [1,3]
C0220908
The subject had donated a unit of blood within the last 56 d or intended to donate within 56 d after completing the study
Beschreibung

Blood donation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0005794
UMLS CUI [2,2]
C1301732
The subject had used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s wort) within 7 d (or 14 d if the drug was a potential enzyme inducer) or 5 half-lives (which ever was longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication would not interfere with the study procedures or compromise subject safety
Beschreibung

unless in the opinion of the Investigator and sponsor the medication would not interfere with the study procedures or compromise subject safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304227
UMLS CUI [1,2]
C0013231
UMLS CUI [1,3]
C0332257
UMLS CUI [1,4]
C0042890
UMLS CUI [1,5]
C1504473
UMLS CUI [1,6]
C0242295
The subject had participated in a clinical study with a New Chemical Entity (NCE) within the past 112 d or any other drug within a clinical study during the previous 84 d
Beschreibung

Participation in a clinical study with a New Chemical Entity (NCE) or any other drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0220806
UMLS CUI [1,4]
C0262926
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0262926
The subject had tested positive for hepatitis C antibody or hepatitis B surface antigen
Beschreibung

Positive testing for hepatitis C antibody or hepatitis B surface antigen

Datentyp

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2]
C0149709
The subject had a positive pre-study urine drug or alcohol breath test screen. A minimum list of drugs that were screened for included amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
Beschreibung

A minimum list of drugs that were screened for included amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines

Datentyp

boolean

Alias
UMLS CUI [1]
C0743300
UMLS CUI [2]
C1112499
A history of regular alcohol consumption exceeding a weekly intake of 21 units, or an average daily intake of 3 units
Beschreibung

Alcohol consumption

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0332174
UMLS CUI [1,3]
C0332173
UMLS CUI [1,4]
C0262926
The subject had a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicated his participation
Beschreibung

The subject had a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicated his participation

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0262926
UMLS CUI [1,4]
C1301624
UMLS CUI [1,5]
C0030699
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0262926
UMLS CUI [2,4]
C1301624
UMLS CUI [2,5]
C0030699
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Ähnliche Modelle

Eligibility criteria

1 Formulare
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility determination
C0013893 (UMLS CUI-1)
Eligibility determination
Item
Did the subject meet all entry criteria (i.e., all "YES" answers for inclusion criteria, all "NO" answers for exclusion criteria)?
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Healthy adult male aged between 18- 55 years
Item
Healthy adult male aged between 18 - 55 years
boolean
C3898900 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Body mass index (BMI)
Item
Body mass index (BMI) within the range 18.5–29.9 kg/m2
boolean
C1305855 (UMLS CUI [1])
Forced exspiratory volume in 1 second (FEV1) and FEV1/Forced Vital Capacity (FVC) ratio
Item
Forced expiratory volume in 1 second (FEV1) ≥80% predicted and a FEV1/Forced Vital Capacity (FVC) ratio ≥0.7
boolean
C0024109 (UMLS CUI [1,1])
C0024119 (UMLS CUI [1,2])
C0849974 (UMLS CUI [1,3])
C0024109 (UMLS CUI [2,1])
C0024119 (UMLS CUI [2,2])
C0429745 (UMLS CUI [2,3])
Informed consent
Item
A signed and dated written informed consent was obtained from the subject
boolean
C0021430 (UMLS CUI [1])
Comprehension of and Corresponding to protocol requirements, instructions and protocol-stated restrictions
Item
The subject was able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C2348563 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
tobacco use
Item
Subjects who were current non-smokers who had not used any tobacco products in the 6-month period preceding the screening visit and had a pack history of ≤10 pack years (pack history = (number of cigarettes per day/20) x number of years smoked).
boolean
C0543414 (UMLS CUI [1])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
clinically relevant abnormality identified at the screening medical assessment
Item
Any clinically relevant abnormality identified at the screening medical assessment (physical examination/medical history), clinical laboratory tests, or ECG (12-lead or Holter)
boolean
C1704258 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0031809 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C2985739 (UMLS CUI [3,2])
C0022885 (UMLS CUI [3,3])
C1704258 (UMLS CUI [4,1])
C2985739 (UMLS CUI [4,2])
C1623258 (UMLS CUI [4,3])
History of breathing problems
Item
A history of breathing problems (eg history of asthmatic symptoms)
boolean
C0262926 (UMLS CUI [1,1])
C0035203 (UMLS CUI [1,2])
C1254481 (UMLS CUI [1,3])
Abnormal screening ECG
Item
A mean QTc(B) value at screening >430 msec, any of the 3 screening ECGs not within 10% of the mean, a mean PR interval outside the range 120 - 210 msec or an ECG that was not suitable for QT measurements (eg poorly defined termination of the T wave)
boolean
C1623258 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C0489625 (UMLS CUI [1,3])
C0444504 (UMLS CUI [1,4])
C1623258 (UMLS CUI [2,1])
C0220908 (UMLS CUI [2,2])
C0429087 (UMLS CUI [2,3])
C0444504 (UMLS CUI [2,4])
C1623258 (UMLS CUI [3,1])
C0220908 (UMLS CUI [3,2])
C0577807 (UMLS CUI [3,3])
C3827727 (UMLS CUI [3,4])
Supine blood pressure in medical history and at screening
Item
A history of elevated supine blood pressure (BP) or a mean supine BP equal to or higher than 150/90 millimetres of mercury (mm Hg) at screening
boolean
C0005823 (UMLS CUI [1,1])
C0038846 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0005823 (UMLS CUI [2,1])
C0038846 (UMLS CUI [2,2])
C0220908 (UMLS CUI [2,3])
Mean heart rate at screening
Item
A mean heart rate (HR) outside the range 40 - 90 beats per minute (beats/min) at screening
boolean
C0018810 (UMLS CUI [1,1])
C0444504 (UMLS CUI [1,2])
C0220908 (UMLS CUI [1,3])
Blood donation
Item
The subject had donated a unit of blood within the last 56 d or intended to donate within 56 d after completing the study
boolean
C0005794 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0005794 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Use of prescription or non-prescription drugs
Item
The subject had used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s wort) within 7 d (or 14 d if the drug was a potential enzyme inducer) or 5 half-lives (which ever was longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication would not interfere with the study procedures or compromise subject safety
boolean
C0304227 (UMLS CUI [1,1])
C0013231 (UMLS CUI [1,2])
C0332257 (UMLS CUI [1,3])
C0042890 (UMLS CUI [1,4])
C1504473 (UMLS CUI [1,5])
C0242295 (UMLS CUI [1,6])
Participation in a clinical study with a New Chemical Entity (NCE) or any other drug
Item
The subject had participated in a clinical study with a New Chemical Entity (NCE) within the past 112 d or any other drug within a clinical study during the previous 84 d
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0220806 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
C2348568 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
Positive testing for hepatitis C antibody or hepatitis B surface antigen
Item
The subject had tested positive for hepatitis C antibody or hepatitis B surface antigen
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Positive pre-study urine drug or alcohol breath test screen
Item
The subject had a positive pre-study urine drug or alcohol breath test screen. A minimum list of drugs that were screened for included amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines
boolean
C0743300 (UMLS CUI [1])
C1112499 (UMLS CUI [2])
Alcohol consumption
Item
A history of regular alcohol consumption exceeding a weekly intake of 21 units, or an average daily intake of 3 units
boolean
C0001948 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
C0332173 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
History of drug or other allergy
Item
The subject had a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicated his participation
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C1301624 (UMLS CUI [1,4])
C0030699 (UMLS CUI [1,5])
C0020517 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C1301624 (UMLS CUI [2,4])
C0030699 (UMLS CUI [2,5])
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