Information:
Fel:
ID
25692
Beskrivning
Demography, Eligibility - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876 Study ID: 100789 Clinical Study ID: NKV100789 Study Title: A two-part, dose-rising study to evaluate the safety, tolerability and pharmacokinetics of single intravenous doses of GW679769 when administered alone and in combination with intravenous or oral doses of dexamethasone in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00291876 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: casopitant Trade Name: Rezonic,Zunrisa; Zunrisa,Rezonic Study Indication: Nausea and Vomiting, Chemotherapy-Induced
Nyckelord
Versioner (2)
- 2017-09-10 2017-09-10 -
- 2017-09-10 2017-09-10 -
Uppladdad den
10 september 2017
DOI
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Licens
Creative Commons BY-NC 3.0
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Demography, Eligibility - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876
Demography, Eligibility - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876
Similar models
Demography, Eligibility - GSK Study: GW679769 administered alone vs. with dexamethasone - Evaluation of safety, tolerability and pharmacokinetics NCT00291876
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Visit date
Item
Collect Date
date
C1320303 (UMLS CUI [1])
Visit time
Item
Collect Time
time
C0545082 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
Race
Item
Race
text
C0034510 (UMLS CUI [1])
Other race
Item
Other race
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Gender
Item
Sex
text
C0079399 (UMLS CUI [1])
Height
Item
Heigth
integer
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Subject type
Item
Subject type
text
C2348569 (UMLS CUI [1])
BMI
Item
BMI
float
C1305855 (UMLS CUI [1])
Subject group
Item
Subject group
text
C1710223 (UMLS CUI [1])
eligibility
Item
Does the subject meet the following criteria? Each question must be answered "'Yes" for Inclusion and "No" for Exclusion.
text
C0013893 (UMLS CUI [1])
healthy between 18 and 55 years
Item
Is the subject a healthy male or female between 18 and 55 years of age (inclusive)?
boolean
C3898900 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0001779 (UMLS CUI [1,2])
childbearing potential
Item
Is the subject a male or a female of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or post-menopausal females defined as being amenorrheic for greater than 2 years and having estradiol and FSH levels consisten with menopause?
boolean
C3831118 (UMLS CUI [1])
BMI
Item
Is the subjects body mass index (BMI) between 19 to 30 kg/m2?
boolean
C1305855 (UMLS CUI [1])
informed consent
Item
Is the subject capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form?
boolean
C0021430 (UMLS CUI [1])
screening finding
Item
Did the subject have the presence of any clinically significant and relevant abnormality identified on the screening medical assessment, 12 lead ECG or laboratory examination?
boolean
C1409616 (UMLS CUI [1])
allergy dexamethasone
Item
Does the subject have a known allergy or intolerance to dexamethasone or sulfites?
boolean
C0013182 (UMLS CUI [1,1])
C0011777 (UMLS CUI [1,2])
C0011777 (UMLS CUI [1,2])
osteoporosis
Item
Is the subject a women with a positive hCG at screening or predose or a known history of osteoporosis?
boolean
C0029456 (UMLS CUI [1,1])
C1141639 (UMLS CUI [1,2])
C1141639 (UMLS CUI [1,2])
concomitant medication
Item
Did the subject fail to discontinue prescription (including hormone replacement therapy) or nonprescription drugs or vitamins within 14 days prior to the first dose of study medication and throughout the duration of the study?
boolean
C2347852 (UMLS CUI [1])
medical history
Item
Does the subject have a history of seizures, glaucoma, recent fracture, atopic disorder (including allergic rhinitis, atopic dermatitis and asthma), eosinophilia, significant psychiatric history, active infection, chronic herpes, muscle disorder and open wounds?
boolean
C0262926 (UMLS CUI [1])
medical history
Item
Does the subject have a history of severe heartburn within the last 6 months, history of persistent dyspepsia within the last 6 months, history of gastrointestinal bleeding and history of stomach or duodenal ulcers unless the subject has been successfully treated with H.Qylori eradication therapy and has been asymptomatic within the last year?
boolean
C0262926 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,2])
cytochrome P450 3A inducer or inhibitors
Item
Has the subject consumed suspected inhibitors/inducers of cytochrome P450 3A enzymes? These include drugs (ketoconazole, itraconazole, fluconazole, voriconazole, clotrimazole - oral or vaginal, erythromycin, clarithromycin, azithromycin, troleandomycin, phenytoin, carbamazepine, phenobarbital, rifampin, cimetidine, ciprofloxacin, diltiazem, fluoxetine, cyclosporin, FK506, verapmil, nefazedone, rifabutin or HIV protease inhibitors) and foods (red wine, grapefruit, grapefruit juice, cabbage and brussel sprouts) within 14 days prior to the first dose of study medication and throughout the duration of the study?
boolean
C3830625 (UMLS CUI [1])
C3830624 (UMLS CUI [2])
C3830624 (UMLS CUI [2])
herbal or dietary supplements
Item
Has the subject failed to discontinue herbal or dietary supplements including (but not limited to) St. John's Wort, kava, ephedra (mahuang), gingko biloba, DHEA, yohimbe, saw palmetto ginseng, red yeast rice, excessive doses of vitamins (greater than 2 times)...
boolean
C0242295 (UMLS CUI [1])
C1504473 (UMLS CUI [2])
C1504473 (UMLS CUI [2])
blood donor
Item
Has the subject donated blood in excess of 500 ml within 56 days prior to dosing?
boolean
C0005795 (UMLS CUI [1])
investigational drug
Item
Has the subject received treatment with an investigational drug within 30 day s or 5 half- lives (whichever is longer) preceding the first dose of study medication?
boolean
C0013230 (UMLS CUI [1])
drug screeing
Item
Did the subject have a positive urine drug/cotinine screen?
boolean
C0743295 (UMLS CUI [1])
alcohol consumption
Item
Does the subject have a history of regular alcohol consumption exceeding 7 drinks/week for women or 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening?
boolean
C0001948 (UMLS CUI [1])
smoking
Item
Does the subject smoke or have they smoked or used any nicotine-containing products in the last three months?
boolean
C0543414 (UMLS CUI [1])
HIV, Hepatitis B or Hepatitis C test positive
Item
Did the subject have a positive HIV, Hepatitis B or Hepatitis C test?
boolean
C1321876 (UMLS CUI [1])
C2363788 (UMLS CUI [2])
C2363789 (UMLS CUI [3])
C2363788 (UMLS CUI [2])
C2363789 (UMLS CUI [3])