ID
41146
Beskrivning
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)
Nyckelord
Versioner (1)
- 2020-06-30 2020-06-30 -
Rättsinnehavare
GlaxoSmithKline
Uppladdad den
30 juni 2020
DOI
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Licens
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
Beskrivning
Eligibility Question
Alias
- UMLS CUI-1
- C1516637
Beskrivning
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
Beskrivning
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)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1708335
- UMLS CUI [1,2]
- C0079399
Beskrivning
2. Aged between 18 - 50 years
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0001779
Beskrivning
Pack years = (cigarettes per day smoked/20) x number of years smoked
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0337672
- UMLS CUI [2,1]
- C1519384
- UMLS CUI [2,2]
- C1277691
Beskrivning
4. Normal spirometry (FEV1 >=80% of predicted, FEV1/FVC >= 70%)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0037981
- UMLS CUI [2]
- C0429706
- UMLS CUI [3]
- C0730560
Beskrivning
5. A signed and dated written informed consent is obtained from the subject
Datatyp
text
Alias
- UMLS CUI [1]
- C0021430
Beskrivning
6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0525058
Beskrivning
7. Available to complete the study.
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0470187
- UMLS CUI [1,2]
- C2348577
Beskrivning
8. Body mass index within the range 18.0 to 34.9 kg/m2
Datatyp
boolean
Alias
- UMLS CUI [1]
- C1305855
Beskrivning
9. Response to Ipratropium bromide defined as
Datatyp
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
Beskrivning
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
Beskrivning
1. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/ medical history), clinical laboratory tests, or ECG (12-Lead or Holter)
Datatyp
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
Beskrivning
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.
Datatyp
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
Beskrivning
3. QTC interval | Electrocardiography | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0489625
- UMLS CUI [2]
- C1623258
- UMLS CUI [3]
- C0429087
- UMLS CUI [4]
- C1287082
- UMLS CUI [5]
- C0438167
Beskrivning
4. A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg at screening
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005823
- UMLS CUI [1,2]
- C0205250
Beskrivning
5. A mean heart rate outside the range 40 - 90 bpm at screening.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0018810
Beskrivning
6. History of use of tobacco or nicotine containing products within 6 months of screening, or positive urine cotinine at screening.
Datatyp
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
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0005794
- UMLS CUI [2,1]
- C0178602
- UMLS CUI [2,2]
- C0205435
- UMLS CUI [3]
- C0444496
Beskrivning
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.
Datatyp
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
Beskrivning
9. Take prescription medications | Before; Dosage | Drugs, Non-Prescription | Safety Issue | Affecting; research results
Datatyp
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
Beskrivning
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
Datatyp
boolean
Alias
- UMLS CUI [1]
- C2348568
Beskrivning
11. The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if tested according to site GOP's)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0281863
- UMLS CUI [2]
- C0149709
- UMLS CUI [3]
- C0019682
Beskrivning
12. The subject has a positive drugs-of-abuse test
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0373483
- UMLS CUI [1,2]
- C1514241
Beskrivning
Note: The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2188602
- UMLS CUI [1,2]
- C1514241
Beskrivning
14. The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0085762
Beskrivning
15. The subject is unable to use the DISKUS™ and HandiHaler devices correctly
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C1524063
- UMLS CUI [1,2]
- C0021461
- UMLS CUI [1,3]
- C1553480
Beskrivning
16. The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethismography)
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0008909
- UMLS CUI [2]
- C0032221
Beskrivning
17. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of it's derivates.
Datatyp
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
Beskrivning
18. The subject has a known allergy or hypersensitivity to the excipient lactose monohydrate.
Datatyp
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])