ID

32141

Beskrivning

Study ID: 105548 Clinical Study ID: HZA105548 Study Title: A double-blind, randomized, placebo-controlled, repeat dose, 2-way crossover drug interaction study to investigate the pharmacokinetic and pharmacodynamic effects following administration of fluticasone furoate/GW642444M Inhalation Powder with ketoconazole Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01165125 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate/vilanterol; vilanterol Trade Name: Relvar; vilanterol Study Indication: Asthma

Nyckelord

Versioner (1)
  1. 2018-10-21 2018-10-21 -
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

21 oktober 2018

DOI

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Creative Commons BY-NC 3.0
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Pharmacokinetic and pharmacodynamic effects following administration of fluticasone Inhalation Powder with ketoconazole NCT01165125

Engelsk

Electronically Transferred Data, Vital Signs, ECG, Investigational Product, Pharmacodynamics Cortisol - Period 2; Day 1- 4

1 Formulär  
Electronically transferred lab data - Period 2; Day 1 - 4
Beskrivning

Electronically transferred lab data - Period 2; Day 1 - 4

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C1320722
Hematology Date and time sample taken
Beskrivning

Hematology Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0018943
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Clinical Chemistry Date and time sample taken
Beskrivning

Clinical Chemistry Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0008000
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Urinalysis Date and time sample taken
Beskrivning

Urinalysis Date and time sample taken

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0042014
UMLS CUI [1,2]
C0200345
UMLS CUI [1,3]
C1264639
Dosing date and time - Vital signs
Beskrivning

Dosing date and time - Vital signs

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date and time
Beskrivning

Dosing date and time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
Blood Pressure and Heart rate
Beskrivning

Blood Pressure and Heart rate

Alias
UMLS CUI-1
C0005823
UMLS CUI-2
C0018810
Actual time
Beskrivning

Actual Time

Datatyp

time

Alias
UMLS CUI [1]
C0040223
Blood pressure (systolic/ diastolic)
Beskrivning

Blood Pressure

Datatyp

text

Måttenheter
  • mmHg
Alias
UMLS CUI [1]
C0005823
mmHg
Heart rate
Beskrivning

heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
Dosing date and time - ECG
Beskrivning

Dosing date and time - ECG

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0178602
UMLS CUI-3
C0011008
UMLS CUI-4
C0040223
Dosing date and time
Beskrivning

Dosing date and time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
12- Lead ECG
Beskrivning

12- Lead ECG

Alias
UMLS CUI-1
C0430456
Time of ECG
Beskrivning

Time of ECG

Datatyp

time

Alias
UMLS CUI [1,1]
C0013798
UMLS CUI [1,2]
C0040223
Heart rate
Beskrivning

heart rate

Datatyp

integer

Måttenheter
  • beats/min
Alias
UMLS CUI [1]
C0018810
beats/min
PR Interval
Beskrivning

Electrocardiogram: P-R interval

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429087
msec
QRS Duration
Beskrivning

QRS complex duration (observable entity)

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C0429025
msec
Uncorrected QT Interval
Beskrivning

QT interval - finding

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1]
C1287082
msec
Method of QTc Calculation
Beskrivning

Electrocardiogram QT corrected interval; Evaluation Method

Datatyp

integer

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
If QTc interval was calculated mechanical, check method of caluclation
Beskrivning

Electrocardiogram QT corrected interval; Evaluation Method; Mechanical Methods

Datatyp

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0443254
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
Beskrivning

QTcB - Bazett's Correction Formula; Mechanical Methods

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C1882512
UMLS CUI [1,2]
C0443254
msec
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
Beskrivning

QTcF - Fridericia's Correction Formula; Mechanical Methods; Finding

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C1882513
UMLS CUI [1,2]
C0443254
UMLS CUI [1,3]
C0243095
msec
If QTc interval was calcualted manually, check method of caluclation.
Beskrivning

Electrocardiogram QT corrected interval; Evaluation Method; Manual

Datatyp

text

Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C2911685
UMLS CUI [1,3]
C0175674
If QTc interval was calculated manually with RR interval, enter finding.
Beskrivning

Electrocardiogram QT corrected interval; Manual; Finding

Datatyp

float

Måttenheter
  • msec
Alias
UMLS CUI [1,1]
C0855331
UMLS CUI [1,2]
C0175674
UMLS CUI [1,3]
C0243095
msec
Result of ECG
Beskrivning

EKG finding

Datatyp

integer

Alias
UMLS CUI [1]
C0438154
Investigational Product
Beskrivning

Investigational Product

Alias
UMLS CUI-1
C0304229
Day 1 Ketoconazole - Start date/ time of dose
Beskrivning

Start date/ time of dose

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C2983667
Day 1 Ketoconazole - Container Number
Beskrivning

Container Number

Datatyp

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0180098
UMLS CUI [2,2]
C0237753
Day 1 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beskrivning

Correct treatment during dosage interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2349182
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1272706
UMLS CUI [2,5]
C0347984
Day 1 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
Beskrivning

Reasons for wrong treatment

Datatyp

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3827420
UMLS CUI [2,3]
C3146298
Day 2 Ketoconazole - Start date/ time of dose
Beskrivning

Start date/ time of dose

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C2983667
Day 2 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beskrivning

Correct treatment during dosage interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2349182
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1272706
UMLS CUI [2,5]
C0347984
Day 2 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
Beskrivning

Reasons for wrong treatment

Datatyp

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3827420
UMLS CUI [2,3]
C3146298
Day 3 Ketoconazole - Start date/ time of dose
Beskrivning

Start date/ time of dose

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C2983667
Day 3 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beskrivning

Correct treatment during dosage interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2349182
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1272706
UMLS CUI [2,5]
C0347984
Day 3 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
Beskrivning

Reasons for wrong treatment

Datatyp

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3827420
UMLS CUI [2,3]
C3146298
Day 4 Ketoconazole - Start date/ time of dose
Beskrivning

Start date/ time of dose

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0022625
UMLS CUI [1,2]
C2983667
Day 4 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
Beskrivning

Correct treatment during dosage interval

Datatyp

boolean

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2349182
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
C1272706
UMLS CUI [2,5]
C0347984
Day 4 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
Beskrivning

Reasons for wrong treatment

Datatyp

text

Alias
UMLS CUI [1]
C0022625
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C3827420
UMLS CUI [2,3]
C3146298
Pharmacodynamics - Cortisol
Beskrivning

Pharmacodynamics - Cortisol

Alias
UMLS CUI-1
C0851347
UMLS CUI-2
C0020268
Dosing date/ time
Beskrivning

Dosing date/ time

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0040223
Date/ time of sample
Beskrivning

Date/ time of sample

Datatyp

datetime

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0040223
UMLS CUI [1,3]
C0200345
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Similar models

Electronically Transferred Data, Vital Signs, ECG, Investigational Product, Pharmacodynamics Cortisol - Period 2; Day 1- 4

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Electronically transferred lab data - Period 2; Day 1 - 4
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
Hematology Date and time sample taken
Item
Hematology Date and time sample taken
datetime
C0018943 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Clinical Chemistry Date and time sample taken
Item
Clinical Chemistry Date and time sample taken
datetime
C0008000 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Item Group
Dosing date and time - Vital signs
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing date and time
Item
Dosing date and time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Blood Pressure and Heart rate
C0005823 (UMLS CUI-1)
C0018810 (UMLS CUI-2)
Actual Time
Item
Actual time
time
C0040223 (UMLS CUI [1])
Blood Pressure
Item
Blood pressure (systolic/ diastolic)
text
C0005823 (UMLS CUI [1])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Item Group
Dosing date and time - ECG
C0013227 (UMLS CUI-1)
C0178602 (UMLS CUI-2)
C0011008 (UMLS CUI-3)
C0040223 (UMLS CUI-4)
Dosing date and time
Item
Dosing date and time
datetime
C0013227 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
12- Lead ECG
C0430456 (UMLS CUI-1)
Time of ECG
Item
Time of ECG
time
C0013798 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
heart rate
Item
Heart rate
integer
C0018810 (UMLS CUI [1])
Electrocardiogram: P-R interval
Item
PR Interval
float
C0429087 (UMLS CUI [1])
QRS complex duration (observable entity)
Item
QRS Duration
float
C0429025 (UMLS CUI [1])
QT interval - finding
Item
Uncorrected QT Interval
float
C1287082 (UMLS CUI [1])
Item
Method of QTc Calculation
integer
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
Electrocardiogram QT corrected interval; Evaluation Method
Code List
Method of QTc Calculation
CL Item
Machine; record QTc value(s) generated by the machine (1)
CL Item
Manual; record the RR interval that precedes the measured QT interval (2)
Item
If QTc interval was calculated mechanical, check method of caluclation
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0443254 (UMLS CUI [1,3])
undefined item
Code List
If QTc interval was calculated mechanical, check method of caluclation
CL Item
QTcB (Bazett) (B)
CL Item
QTcF (Fridericia) (F)
QTcB - Bazett's Correction Formula; Mechanical Methods
Item
If QTc interval was calculated mechanically with Bazett's formula, enter finding.
float
C1882512 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
QTcF - Fridericia's Correction Formula; Mechanical Methods; Finding
Item
If QTc interval was calculated mechanically with Fridericia's formula, enter finding.
float
C1882513 (UMLS CUI [1,1])
C0443254 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
If QTc interval was calcualted manually, check method of caluclation.
text
C0855331 (UMLS CUI [1,1])
C2911685 (UMLS CUI [1,2])
C0175674 (UMLS CUI [1,3])
undefined item
Code List
If QTc interval was calcualted manually, check method of caluclation.
CL Item
RR interval (RR)
CL Item
RR interval not available (NA)
Electrocardiogram QT corrected interval; Manual; Finding
Item
If QTc interval was calculated manually with RR interval, enter finding.
float
C0855331 (UMLS CUI [1,1])
C0175674 (UMLS CUI [1,2])
C0243095 (UMLS CUI [1,3])
Item
Result of ECG
integer
C0438154 (UMLS CUI [1])
EKG finding
Code List
Result of ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (complete the ECG abnormality form for all significant abnormalities, and additionally complete the AE form if the abnormality meets the protocol definition for an AE) (3)
CL Item
No result (not available) (4)
Item Group
Investigational Product
C0304229 (UMLS CUI-1)
Start date/ time of dose
Item
Day 1 Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
Container Number
Item
Day 1 Ketoconazole - Container Number
text
C0022625 (UMLS CUI [1])
C0180098 (UMLS CUI [2,1])
C0237753 (UMLS CUI [2,2])
Correct treatment during dosage interval
Item
Day 1 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Day 1 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Start date/ time of dose
Item
Day 2 Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
Correct treatment during dosage interval
Item
Day 2 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Day 2 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Start date/ time of dose
Item
Day 3 Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
Correct treatment during dosage interval
Item
Day 3 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Day 3 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Start date/ time of dose
Item
Day 4 Ketoconazole - Start date/ time of dose
datetime
C0022625 (UMLS CUI [1,1])
C2983667 (UMLS CUI [1,2])
Correct treatment during dosage interval
Item
Day 4 Ketoconazole - Did the subject receive the correct treatment (e.g., treatment which the subject was assigned to) during this dosing interval?
boolean
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2349182 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C1272706 (UMLS CUI [2,4])
C0347984 (UMLS CUI [2,5])
Reasons for wrong treatment
Item
Day 4 Ketoconazole - If the subject did not receive the correct treatment during this dosing interval, record reason(s).
text
C0022625 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C3827420 (UMLS CUI [2,2])
C3146298 (UMLS CUI [2,3])
Item Group
Pharmacodynamics - Cortisol
C0851347 (UMLS CUI-1)
C0020268 (UMLS CUI-2)
Dosing date/ time
Item
Dosing date/ time
datetime
C0178602 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
Date/ time of sample
Item
Date/ time of sample
datetime
C0011008 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
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