ID

34917

Beskrivning

Study ID: 101888 Clinical Study ID: FFR101888 Study Title: A randomised, placebo-controlled, four way crossover study to evaluate the effect of double-blind 4000 mcg of orally inhaled GW685698X and of 6.25 mg cellobiose octa-acetate on electrocardiographic parameters, with single-blind 400 mg of oral moxifloxacin as a positive control, in 40 healthy male and female subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone furoate Trade Name: Veramyst,Avamys,Allermist Study Indication: Rhinitis, Allergic, Perennial The study consists of a screening, 4 treatment periods (TP) and a follow-up visit. For each TP there is a Day-1 (D-1) and a Day1 (D1). This document contains eligibility determination. It has to be filled in for screening.

Nyckelord

Versioner (1)
  1. 2019-02-04 2019-02-04 -
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GlaxoSmithKline

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4 februari 2019

DOI

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Effect of inhaled Fluticasone furoate and cellobiose octa-acetate on electrocardiographic parameters in healthy subjects, Study-ID: 101888

Engelsk

Eligibility criteria

1 Formulär  
  1. StudyEvent: ODM
    1. Eligibility criteria
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Beskrivning

Subject number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Visit Date
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Eligibility question
Beskrivning

Eligibility question

Alias
UMLS CUI-1
C1516637
Did the subject meet all entry criteria?
Beskrivning

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if they failed any inclusion or exclusion criteria below

Datatyp

text

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy male or female
Beskrivning

A female is eligible to enter and participate in the study if she is of : a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is post menopausal. For the purposes of this study, post menopausal is defined as 1 year without menses (FSH/LH will be also tested to confirm menopausal status); or b. Child bearing potential, has a negative pregnancy test (urine) at entry, and agrees to one of the following acceptable contraceptive methods when used consistently and correctly (i.e., in accordance with the approved product label and the instructions of a physician for the duration of the study - screening visit to follow-up contact): Complete abstinence from intercourse from first visit, throughout the treatment phase, and for 2 weeks following study completion; or Sterilisation of male partner; or Implants of levonorgestrel inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or Injectable progestogen administered for at least 1 month prior to the study medication administration and administered for 1 month following study completion; or Oral contraceptive (combined or progestogen only) administered for a least one monthly cycle prior to study medication administration; or An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1 % per year; or Any other methods with published data showing that the highest expected failure rate is less than 1% per year.

Datatyp

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2]
C0079399
UMLS CUI [3]
C3831118
Aged between 18 and 65 years, inclusive, at the time of screening
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Body weight >= 50kg and BMI within the range of 19 to 31 kg/m2 inclusive.
Beskrivning

BMI=weight kg/height m²

Datatyp

boolean

Alias
UMLS CUI [1]
C1305855
A non-smoker for at least the past 12 months with a pack history <= 5 pack years.
Beskrivning

Smoker status, pack years

Datatyp

boolean

Alias
UMLS CUI [1]
C1519386
UMLS CUI [2]
C1277691
No significant abnormality on clinical examination.
Beskrivning

A subject with a minor clinical abnormality may be included only if the investigator considers that the abnormality will not introduce additional risk and will not interfere with the study procedures or outcome.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C2985739
UMLS CUI [1,4]
C0031809
No abnormality on haematology, clinical chemistry or urinalysis examination at the pre-study medical.
Beskrivning

Subjects with laboratory parameters outside the reference range for this age group will only be included if the investigator considers that such findings will not introduce additional risk or interfere with the study procedures or outcome.

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0018941
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C1704258
UMLS CUI [2,3]
C0008000
UMLS CUI [3,1]
C1298908
UMLS CUI [3,2]
C1704258
UMLS CUI [3,3]
C0042014
Normal 12-lead ECG at screening
Beskrivning

Selected, specific screening ECG findings that are considered to be significant abnormalities and would exclude study participation (this is not a complete list - any other finding considered clinically significant, or could interfere with interpretation of the study results, will exclude the subject from study participation): Ventricular rate < 45 beats per minute PR interval > 240 msec Evidence of second - or third - degree atrioventricular (AV) block Pathological Q-waves (> 40 msec or depth greater than 0.4- 0.5 mV) Evidence of ventricular pre-excitation A mean QTcF value at screening >430msec (male)/ >450msec (female) or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave) Evidence of left ventricular hypertrophy (by voltage criteria) Left axis deviation Non-specific intraventricular conduction delay ST-T wave abnormalities Right or left bundle branch block Incomplete right

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0430456
UMLS CUI [1,2]
C0459422
Holter ECG at screening that demonstrates no clinically significant abnormalities or finding that could interfere with interpretation of the study results, when assessed by an appropriately trained and experienced reviewer.
Beskrivning

Holter ECG, no clinically significant abnormalities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013801
UMLS CUI [1,2]
C1298908
UMLS CUI [1,3]
C2985739
UMLS CUI [1,4]
C1704258
Demonstrated ability to use the inhaler device in a satisfactory and repeatable manner.
Beskrivning

Ability of using inhaler device

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1524063
UMLS CUI [1,3]
C0021461
Negative pre-study HIV and hepatitis B and C screen.
Beskrivning

Negative HIV and hepatitis B and C

Datatyp

boolean

Alias
UMLS CUI [1]
C0481430
UMLS CUI [2]
C1619717
UMLS CUI [3]
C1611173
Negative pre-study urine drug screen.
Beskrivning

Negative urine drug screen

Datatyp

boolean

Alias
UMLS CUI [1]
C0920168
Must have given informed consent and signed the study consent form prior to taking part in any study procedures.
Beskrivning

Informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Available to complete the study and all study measurements.
Beskrivning

Available for trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085732
UMLS CUI [1,2]
C1999232
UMLS CUI [1,3]
C2347804
Exclusion criteria
Beskrivning

Exclusion criteria

Alias
UMLS CUI-1
C0680251
As a result of medical interview, physical examination or screening investigations, the responsible physician deems the subject unsuitable for the study.
Beskrivning

Unsuitable for study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C3839996
UMLS CUI [2,1]
C0031809
UMLS CUI [2,2]
C3839996
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C3839996
Prescribed medication within 14 days prior to the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
Beskrivning

Use of prescribed medication prior first dosing day

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0278329
UMLS CUI [1,2]
C2347852
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C2347804
Over-the-counter medicine within 5 days before the first study day, unless the investigator confirms that the medication received will not introduce additional risk or interfere with the study procedures or outcome. Any herbal remedies containing St John's Wort will not be permitted for 4 weeks prior to the first dosing day until the end of the study period (last safety screen).
Beskrivning

Over-the-counter medicine, no herbal remedies (containing St. John's Wort) 4 weeks prior study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013231
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C1298908
UMLS CUI [2,2]
C0025125
UMLS CUI [2,3]
C0936242
UMLS CUI [2,4]
C0332152
UMLS CUI [2,5]
C2347804
History or evidence of drug abuse.
Beskrivning

Drug abuse

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0013146
UMLS CUI [2,1]
C0332120
UMLS CUI [2,2]
C0013146
Weekly alcohol intake of more than 21 units (14 units for females) or an average daily intake of greater than 4 units (3 units for females)
Beskrivning

One unit being equivalent to half pint of beer (220 ml) or 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.

Datatyp

boolean

Alias
UMLS CUI [1]
C0001948
UMLS CUI [2]
C0560578
UMLS CUI [3]
C0560579
History or presence of any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
Beskrivning

Medically significant disease; family history of QT prolongation/ early or sudden cardiac death/ early cardiovascular disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C0150312
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C0012634
UMLS CUI [3,1]
C0241889
UMLS CUI [3,2]
C0855333
UMLS CUI [4,1]
C0241889
UMLS CUI [4,2]
C0085298
UMLS CUI [5,1]
C0241889
UMLS CUI [5,2]
C0007222
A clinically significant abnormality on standard pulmonary function testing, or any other finding that would prevent satisfactory administration of the inhaled study medication. Screening lung function tests will be performed to confirm normal lung function parameters (FEV1 >= 80% predicted).
Beskrivning

Clinically significant abnormality on standard pulmonary function testing, FEV1

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2985739
UMLS CUI [1,2]
C1704258
UMLS CUI [1,3]
C0024119
UMLS CUI [2]
C0748133
Exposure prior to the first dosing day to more than 3 new medicinal entities within 12 months or has participated in a study with a new medicinal entity within 3 months or any other study within 2 months.
Beskrivning

New medicinal entities

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C2348568
If participation in the study will result in the subject having donated more than 450 ml blood within the 2 months prior to screening.
Beskrivning

Blood donation before study

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0008976
Have a history of severe milk protein allergy.
Beskrivning

History of milk protein allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C3889086
The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicates their participation.
Beskrivning

History of drug/ other allergy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0013182
UMLS CUI [2]
C0020517
The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
Beskrivning

Positive hepatitis C antibody or hepatitis B surface antigen

Datatyp

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2]
C0149709
The subject has tested positive for HIV antibodies.
Beskrivning

Positive HIV antibodies

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
A known hypersensitivity to corticosteroids or the excipients of GW685698X (lactose/GOA).
Beskrivning

GW685698X = Fluticasone furoate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0001617
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1948374
Any contraindications to the administration of moxifloxacin, as described in the current Summary of Product Characteristics (Avelox 400 mg tablet, Bayer pie 2004).
Beskrivning

Contraindications for moxifloxacin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0536495
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Similar models

Eligibility criteria

1 Formulär
  1. StudyEvent: ODM
    1. Eligibility criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
text
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Eligibility question
C1516637 (UMLS CUI-1)
Item
Did the subject meet all entry criteria?
text
C1516637 (UMLS CUI [1])
Entry criteria
Code List
Did the subject meet all entry criteria?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Healthy male or female
Item
Healthy male or female
boolean
C1708335 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Age
Item
Aged between 18 and 65 years, inclusive, at the time of screening
boolean
C0001779 (UMLS CUI [1])
BMI
Item
Body weight >= 50kg and BMI within the range of 19 to 31 kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
Smoker status, pack years
Item
A non-smoker for at least the past 12 months with a pack history <= 5 pack years.
boolean
C1519386 (UMLS CUI [1])
C1277691 (UMLS CUI [2])
No significant abnormality on clinical examination
Item
No significant abnormality on clinical examination.
boolean
C1298908 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C0031809 (UMLS CUI [1,4])
No abnormality on haematology, clinical chemistry or urinalysis examination
Item
No abnormality on haematology, clinical chemistry or urinalysis examination at the pre-study medical.
boolean
C1298908 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0018941 (UMLS CUI [1,3])
C1298908 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0008000 (UMLS CUI [2,3])
C1298908 (UMLS CUI [3,1])
C1704258 (UMLS CUI [3,2])
C0042014 (UMLS CUI [3,3])
Normal 12-lead ECG at screening
Item
Normal 12-lead ECG at screening
boolean
C0430456 (UMLS CUI [1,1])
C0459422 (UMLS CUI [1,2])
Holter ECG, no clinically significant abnormalities
Item
Holter ECG at screening that demonstrates no clinically significant abnormalities or finding that could interfere with interpretation of the study results, when assessed by an appropriately trained and experienced reviewer.
boolean
C0013801 (UMLS CUI [1,1])
C1298908 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,3])
C1704258 (UMLS CUI [1,4])
Ability of using inhaler device
Item
Demonstrated ability to use the inhaler device in a satisfactory and repeatable manner.
boolean
C0085732 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,3])
Negative HIV and hepatitis B and C
Item
Negative pre-study HIV and hepatitis B and C screen.
boolean
C0481430 (UMLS CUI [1])
C1619717 (UMLS CUI [2])
C1611173 (UMLS CUI [3])
Negative urine drug screen
Item
Negative pre-study urine drug screen.
boolean
C0920168 (UMLS CUI [1])
Informed consent
Item
Must have given informed consent and signed the study consent form prior to taking part in any study procedures.
boolean
C0021430 (UMLS CUI [1])
Available for trial
Item
Available to complete the study and all study measurements.
boolean
C0085732 (UMLS CUI [1,1])
C1999232 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Unsuitable for study
Item
As a result of medical interview, physical examination or screening investigations, the responsible physician deems the subject unsuitable for the study.
boolean
C0262926 (UMLS CUI [1,1])
C3839996 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2,1])
C3839996 (UMLS CUI [2,2])
C1261322 (UMLS CUI [3,1])
C3839996 (UMLS CUI [3,2])
Use of prescribed medication prior first dosing day
Item
Prescribed medication within 14 days prior to the first dosing day, unless the investigator confirms that it will not introduce additional risk or interfere with the study procedures or outcome.
boolean
C0278329 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C2347804 (UMLS CUI [1,4])
Over-the-counter medicine, no herbal remedies (containing St. John's Wort) 4 weeks prior study
Item
Over-the-counter medicine within 5 days before the first study day, unless the investigator confirms that the medication received will not introduce additional risk or interfere with the study procedures or outcome. Any herbal remedies containing St John's Wort will not be permitted for 4 weeks prior to the first dosing day until the end of the study period (last safety screen).
boolean
C0013231 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C1298908 (UMLS CUI [2,1])
C0025125 (UMLS CUI [2,2])
C0936242 (UMLS CUI [2,3])
C0332152 (UMLS CUI [2,4])
C2347804 (UMLS CUI [2,5])
Drug abuse
Item
History or evidence of drug abuse.
boolean
C0262926 (UMLS CUI [1,1])
C0013146 (UMLS CUI [1,2])
C0332120 (UMLS CUI [2,1])
C0013146 (UMLS CUI [2,2])
Alcohol intake
Item
Weekly alcohol intake of more than 21 units (14 units for females) or an average daily intake of greater than 4 units (3 units for females)
boolean
C0001948 (UMLS CUI [1])
C0560578 (UMLS CUI [2])
C0560579 (UMLS CUI [3])
Medically significant disease; family history of QT prolongation/ early or sudden cardiac death/ early cardiovascular disease
Item
History or presence of any medically significant disease, or any disorder that would introduce additional risk or interfere with the study procedures or outcome. In particular, a family history of QT prolongation, of early or sudden cardiac death or of early cardiovascular disease.
boolean
C0262926 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C0150312 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0241889 (UMLS CUI [3,1])
C0855333 (UMLS CUI [3,2])
C0241889 (UMLS CUI [4,1])
C0085298 (UMLS CUI [4,2])
C0241889 (UMLS CUI [5,1])
C0007222 (UMLS CUI [5,2])
Clinically significant abnormality on standard pulmonary function testing, FEV1
Item
A clinically significant abnormality on standard pulmonary function testing, or any other finding that would prevent satisfactory administration of the inhaled study medication. Screening lung function tests will be performed to confirm normal lung function parameters (FEV1 >= 80% predicted).
boolean
C2985739 (UMLS CUI [1,1])
C1704258 (UMLS CUI [1,2])
C0024119 (UMLS CUI [1,3])
C0748133 (UMLS CUI [2])
New medicinal entities
Item
Exposure prior to the first dosing day to more than 3 new medicinal entities within 12 months or has participated in a study with a new medicinal entity within 3 months or any other study within 2 months.
boolean
C0013230 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Blood donation before study
Item
If participation in the study will result in the subject having donated more than 450 ml blood within the 2 months prior to screening.
boolean
C0005794 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
History of milk protein allergy
Item
Have a history of severe milk protein allergy.
boolean
C0262926 (UMLS CUI [1,1])
C3889086 (UMLS CUI [1,2])
History of drug/ other allergy
Item
The subject has a history of drug or other allergy, which, in the opinion of the responsible physician, contraindicates their participation.
boolean
C0262926 (UMLS CUI [1,1])
C0013182 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2])
Positive hepatitis C antibody or hepatitis B surface antigen
Item
The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
Positive HIV antibodies
Item
The subject has tested positive for HIV antibodies.
boolean
C0019699 (UMLS CUI [1])
Hypersensitivity to corticosteroids/Fluticasone furoate
Item
A known hypersensitivity to corticosteroids or the excipients of GW685698X (lactose/GOA).
boolean
C0020517 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1948374 (UMLS CUI [2,2])
Contraindications for moxifloxacin
Item
Any contraindications to the administration of moxifloxacin, as described in the current Summary of Product Characteristics (Avelox 400 mg tablet, Bayer pie 2004).
boolean
C1301624 (UMLS CUI [1,1])
C0536495 (UMLS CUI [1,2])
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