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ID
32027
Description
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
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Versions (1)
- 10/14/18 10/14/18 -
Copyright Holder
GlaxoSmithKline
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October 14, 2018
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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
Eligibility Question, Subject Identification, Electronically Transferred Lab Data Screening and Day 1 and Randomisation Number
Similar models
Eligibility Question, Subject Identification, Electronically Transferred Lab Data Screening and Day 1 and Randomisation Number
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Clinical Trial Eligibility Criteria | Protocol Violation; Exclusion Criteria; Clinical Trial Eligibility Criteria | Protocol Violation; Inclusion; Clinical Trial Eligibility Criteria
Item
Did the subject meet all the entry criteria? If no, please select all boxes corresponding to violations of any inclusion/ exclusion criteria)
boolean
C1516637 (UMLS CUI [1])
C1709750 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C1709750 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
C1516637 (UMLS CUI [3,3])
C1709750 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C1709750 (UMLS CUI [3,1])
C1512693 (UMLS CUI [3,2])
C1516637 (UMLS CUI [3,3])
CL Item
Healthy male or female between 18 and 64 years of age inclusive, at the time of signing the informed consent. Healthy as determined by a responsible and experienced physician, based on a medical evaluatoin including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population, which are deemed to be clinically relevant, should always be excluded from enrollment. (1)
CL Item
A female subject is eligible to participate if she is of: (2)
CL Item
1) Non- childbearing potential defined as pre- menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 month of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) > 40 MIU/ml and estradiol < 40pg/ml [< 140 pmol/L] is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post- menopausal status prior to study enrollment. For most forms of HRT, at least 2- 4 weeks will elapse between the cessation of therapy and the blood draw; thiss interval depends on the type and dosage of HRT. Following confirmation of their post- menopausal status, they can resume use of HRT during the study without use of a contraceptive method. (3)
CL Item
2) Child- bearing potential and agrees to use on of the contraception methods listed in Section 8.1 for an appropriate periodof time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until completion of the follow- up visit. (4)
CL Item
Body mass index within range of 18.5 - 29.0 kg/m2 inclusive. (3)
CL Item
Subjects who are current non- smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of <= 5 pack years. (4)
CL Item
AST, ALT, alkaline phosphatase and bilirubin <= 1.5x ULN (isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) (5)
CL Item
No significant abnormality on 12- lead ECG at screening, including the following specific requirements: QTcF < 450msec. If an ECG, at screening, demonstrates a QTc(F) >= 450msec, obtain 2 more ECGs at least 5 minutes apart. If two of the three ECGs have QTc(F) >= 450msec, se subject should be considered a screen failure. (6)
CL Item
No clinically significant abnormality on the Holter ECG at screening. (7)
CL Item
FEV1 >= 85% predicted at screening (8)
CL Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions. (9)
CL Item
Able to satisfactorily use the dry powder inhaler. (10)
CL Item
As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the investigator confirms that it is satisfactory for their age. (1)
CL Item
The subject has any history of breathing problems in adult life (i.e. history of asthmatic symptomatology). Screening lung function tests (FEV1) will be performed to confirm normal lung function parameters (>= 85 predicted) (2)
CL Item
Pregnant females as determined by positive serum hCG test at screening or by positive serum/ urine hCG test prior to dosing. (3)
CL Item
Lactating females. (4)
CL Item
The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness. (5)
CL Item
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) (6)
CL Item
Subjects who have suffered a lower respiratory tract infectin within 4 weeksof the screenung visit. (7)
CL Item
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation (8)
CL Item
Any adverse reaction including immediate or delayed hypertensitivity to any betaagonist, sympathomimetic drug, or any intranasal, inhaled or systemic conrtiocoid therapy. Known or suspected sensitivitiy to the constituents of the new powder inhaler (i.e. lactose or magnesium stearate) (9)
CL Item
History of milk protein allergy. (10)
CL Item
Use of prescription or non- prescription drugs, including vitamins, herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and GSK Medical Monitor the medicatoin will not interfere with the study procedures or compromise subject safety. (11)
CL Item
The subject has taken oral corticosteroids less than 8 weeks before the screening visit. (12)
CL Item
The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit. (13)
CL Item
History of alcohol/ drug abuse or dependence within 12 months of the study . Abuse of alcohol is defined as an average weekly intake greater than 21 units or an average daily intake greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a 285mL glass of full strenght beer or 425mL schooner of light beer or 1 (30mL) measure of spirits or 1 glass (100 mL) of wine (NHMRC Guidelines [NHMRC, 2001]) (14)
CL Item
The subjet has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half- lives or twice the duration of the biological effect of the investigational product (whichever is longer) (15)
CL Item
Exposure to more than four new chemical entities within 12 months prior to the first dosing day. (16)
CL Item
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months of the start of the trial. (17)
CL Item
A positive pre- study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. (18)
CL Item
The subject has tested positive for HIV antibodies. (19)
CL Item
A positive pre- study urine drug screen or when randomly tested during the study. (20)
CL Item
Positive carbon monoxide (CO) or alcohol breath test at screening or on admission to the unit. (21)
CL Item
Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of stuy medication. (22)
CL Item
Unwillingness or inability to follow the procedures outlined in the protocol. (23)
CL Item
Subject is mentally or legally incapacitated. (24)
Clinical Trial Subject Unique Identifier
Item
Subject Identification
text
C2348585 (UMLS CUI [1])
Item Group
Electronically transferred lab data - Screening
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
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])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
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])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Urinalysis Date and time sample taken
Item
Urinalysis Date and time sample taken
datetime
C0042014 (UMLS CUI [1,1])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Item Group
Electronically transferred lab data - Day 1
C0022885 (UMLS CUI-1)
C1320722 (UMLS CUI-2)
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])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
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])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0200345 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
Randomisation; Ability
Item
Was the subject able to be randomised?
boolean
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,2])
Randomisation Number
Item
If subject was able to be randomised, provide randomisation number.
text
C0034656 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C1300638 (UMLS CUI [2,1])
C0034656 (UMLS CUI [2,2])
C0085732 (UMLS CUI [1,2])
C1300638 (UMLS CUI [2,1])
C0034656 (UMLS CUI [2,2])
Date of randomisation
Item
If subject was able to be randomised - Date of randomisation
date
C0034656 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])