ID
41146
Beschrijving
Study ID: 103471 Clinical Study ID: 103471 Study Title: A randomised, double blind, placebo-controlled, double dummy, five-way cross over dose-escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single inhaled doses of GSK233705 (20-500µg via DPI), and, tiotropium bromide (18µg via DPI) in healthy male subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Darotropium Bromide Trade Name: Darotropium Bromide Study Indication: Chronic Obstructive Pulmonary Disease (COPD)
Trefwoorden
Versies (1)
- 30-06-20 30-06-20 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
30 juni 2020
DOI
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Licentie
Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)
Eligibility Question
- StudyEvent: ODM
Beschrijving
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beschrijving
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beschrijving
Note: Healthy subjects are defined as individuals who are free from clinically significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease or malignancy as determined by medical history, physical examination, laboratory studies, and other tests (including ECG)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1708335
- UMLS CUI [1,2]
- C0079399
Beschrijving
2. Aged between 18 - 50 years
Datatype
boolean
Alias
- UMLS CUI [1]
- C0001779
Beschrijving
Pack years = (cigarettes per day smoked/20) x number of years smoked
Datatype
boolean
Alias
- UMLS CUI [1]
- C0337672
- UMLS CUI [2,1]
- C1519384
- UMLS CUI [2,2]
- C1277691
Beschrijving
4. Normal spirometry (FEV1 >=80% of predicted, FEV1/FVC >= 70%)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0037981
- UMLS CUI [2]
- C0429706
- UMLS CUI [3]
- C0730560
Beschrijving
5. A signed and dated written informed consent is obtained from the subject
Datatype
text
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0525058
Beschrijving
7. Available to complete the study.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C2348577
Beschrijving
8. Body mass index within the range 18.0 to 34.9 kg/m2
Datatype
boolean
Alias
- UMLS CUI [1]
- C1305855
Beschrijving
9. Response to Ipratropium bromide defined as
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0700580
- UMLS CUI [1,2]
- C0521982
- UMLS CUI [2]
- C0442805
- UMLS CUI [3,1]
- C0439565
- UMLS CUI [3,2]
- C1442488
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beschrijving
1. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/ medical history), clinical laboratory tests, or ECG (12-Lead or Holter)
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2985739
- UMLS CUI [2]
- C0031809
- UMLS CUI [3]
- C0262926
- UMLS CUI [4]
- C0022885
- UMLS CUI [5]
- C1623258
- UMLS CUI [6]
- C0013801
Beschrijving
2. A history of breathing problems (i.e. history of asthmatic symptomatology). Screening lung function tests (FEV1, FVC and sGaw) will be performed to confirm normal lung function parameters.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0035203
- UMLS CUI [1,3]
- C1254481
- UMLS CUI [2]
- C0004096
- UMLS CUI [3]
- C0024119
- UMLS CUI [4]
- C0748133
- UMLS CUI [5]
- C1287681
Beschrijving
3. QTC interval | Electrocardiography | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal
Datatype
boolean
Alias
- UMLS CUI [1]
- C0489625
- UMLS CUI [2]
- C1623258
- UMLS CUI [3]
- C0429087
- UMLS CUI [4]
- C1287082
- UMLS CUI [5]
- C0438167
Beschrijving
4. A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg at screening
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0205250
Beschrijving
5. A mean heart rate outside the range 40 - 90 bpm at screening.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0018810
Beschrijving
6. History of use of tobacco or nicotine containing products within 6 months of screening, or positive urine cotinine at screening.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0841002
- UMLS CUI [2,1]
- C0439861
- UMLS CUI [2,2]
- C0332256
- UMLS CUI [2,3]
- C0028040
- UMLS CUI [3,1]
- C1697737
- UMLS CUI [3,2]
- C1446409
Beschrijving
7. The subject has donated a unit of blood within a month prior to the first dosing occasion or intends to donate within a month of the end of the study
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005794
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0205435
- UMLS CUI [3]
- C0444496
Beschrijving
8. The subject is currently taking regular (or course of) medication, whether prescribed or not, including vitamins and herbal remedies such as St. John's Wort.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0205272
- UMLS CUI [2]
- C0278329
- UMLS CUI [3]
- C0042890
- UMLS CUI [4]
- C0025125
- UMLS CUI [5]
- C0813171
Beschrijving
9. Take prescription medications | Before; Dosage | Drugs, Non-Prescription | Safety Issue | Affecting; research results
Datatype
boolean
Alias
- UMLS CUI [1]
- C3843193
- UMLS CUI [2,1]
- C0332152
- UMLS CUI [2,2]
- C0178602
- UMLS CUI [3]
- C0013231
- UMLS CUI [4]
- C2911688
- UMLS CUI [5,1]
- C0392760
- UMLS CUI [5,2]
- C0683954
Beschrijving
10. The subject has participated in a study with a new molecular entity or any other trial within a period of 3-months prior to dosing
Datatype
boolean
Alias
- UMLS CUI [1]
- C2348568
Beschrijving
11. The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if tested according to site GOP's)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0281863
- UMLS CUI [2]
- C0149709
- UMLS CUI [3]
- C0019682
Beschrijving
12. The subject has a positive drugs-of-abuse test
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C1514241
Beschrijving
Note: The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2188602
- UMLS CUI [1,2]
- C1514241
Beschrijving
14. The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085762
Beschrijving
15. The subject is unable to use the DISKUS™ and HandiHaler devices correctly
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0021461
- UMLS CUI [1,3]
- C1553480
Beschrijving
16. The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethismography)
Datatype
boolean
Alias
- UMLS CUI [1]
- C0008909
- UMLS CUI [2]
- C0032221
Beschrijving
17. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of it's derivates.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C0700580
- UMLS CUI [2,1]
- C0020517
- UMLS CUI [2,2]
- C1306772
- UMLS CUI [3,1]
- C0020517
- UMLS CUI [3,2]
- C0004259
Beschrijving
18. The subject has a known allergy or hypersensitivity to the excipient lactose monohydrate.
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1658042
Similar models
Eligibility Question
- StudyEvent: ODM
C0079399 (UMLS CUI [1,2])
C1519384 (UMLS CUI [2,1])
C1277691 (UMLS CUI [2,2])
C0429706 (UMLS CUI [2])
C0730560 (UMLS CUI [3])
C0525058 (UMLS CUI [1,2])
C2348577 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,2])
C0442805 (UMLS CUI [2])
C0439565 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
C2985739 (UMLS CUI [1,2])
C0031809 (UMLS CUI [2])
C0262926 (UMLS CUI [3])
C0022885 (UMLS CUI [4])
C1623258 (UMLS CUI [5])
C0013801 (UMLS CUI [6])
C0035203 (UMLS CUI [1,2])
C1254481 (UMLS CUI [1,3])
C0004096 (UMLS CUI [2])
C0024119 (UMLS CUI [3])
C0748133 (UMLS CUI [4])
C1287681 (UMLS CUI [5])
C1623258 (UMLS CUI [2])
C0429087 (UMLS CUI [3])
C1287082 (UMLS CUI [4])
C0438167 (UMLS CUI [5])
C0205250 (UMLS CUI [1,2])
C0439861 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0028040 (UMLS CUI [2,3])
C1697737 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
C0178602 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0444496 (UMLS CUI [3])
C0205272 (UMLS CUI [1,2])
C0278329 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C0025125 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
C0332152 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0013231 (UMLS CUI [3])
C2911688 (UMLS CUI [4])
C0392760 (UMLS CUI [5,1])
C0683954 (UMLS CUI [5,2])
C0149709 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
C1514241 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,2])
C0021461 (UMLS CUI [1,2])
C1553480 (UMLS CUI [1,3])
C0032221 (UMLS CUI [2])
C0700580 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1306772 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0004259 (UMLS CUI [3,2])
C1658042 (UMLS CUI [1,2])