ID

41146

Description

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)

Keywords

Versions (1)
  1. 6/30/20 6/30/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

June 30, 2020

DOI

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License

Creative Commons BY-NC 4.0
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Safety, tolerability, pharmacokinetics and pharmacodynamics of GSK233705 and tiotropium bromide (103471)

English

Eligibility Question

1 forms  
  1. StudyEvent: ODM
    1. Eligibility Question
Administrative
Description

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Description

Subject Identifier

Data type

text

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Description

Eligibility Question

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

Did the subject meet all the entry criteria?

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Healthy male subjects
Description

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)

Data type

boolean

Alias
UMLS CUI [1,1]
C1708335
UMLS CUI [1,2]
C0079399
2. Aged between 18 - 50 years
Description

2. Aged between 18 - 50 years

Data type

boolean

Alias
UMLS CUI [1]
C0001779
3. Non-smokers (never smoked or not smoking >6 month with <10 pack years history)
Description

Pack years = (cigarettes per day smoked/20) x number of years smoked

Data type

boolean

Alias
UMLS CUI [1]
C0337672
UMLS CUI [2,1]
C1519384
UMLS CUI [2,2]
C1277691
4. Normal spirometry (FEV1 >=80% of predicted, FEV1/FVC >= 70%)
Description

4. Normal spirometry (FEV1 >=80% of predicted, FEV1/FVC >= 70%)

Data type

boolean

Alias
UMLS CUI [1]
C0037981
UMLS CUI [2]
C0429706
UMLS CUI [3]
C0730560
5. A signed and dated written informed consent is obtained from the subject
Description

5. A signed and dated written informed consent is obtained from the subject

Data type

text

Alias
UMLS CUI [1]
C0021430
6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Description

6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0525058
7. Available to complete the study.
Description

7. Available to complete the study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C2348577
8. Body mass index within the range 18.0 to 34.9 kg/m2
Description

8. Body mass index within the range 18.0 to 34.9 kg/m2

Data type

boolean

Alias
UMLS CUI [1]
C1305855
9. Response to Ipratropium bromide defined as an increase in sGaw of >= 25% over pre-dose baseline at 2 h following 80ug ipratropium bromide; or a documented increase in sGaw of >= 25% over pre-dose baseline at 2h following of 80ug of ipratropium bromide within 3 month of screening
Description

9. Response to Ipratropium bromide defined as

Data type

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
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
1. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/ medical history), clinical laboratory tests, or ECG (12-Lead or Holter)
Description

1. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/ medical history), clinical laboratory tests, or ECG (12-Lead or Holter)

Data type

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
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.
Description

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.

Data type

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
3. A mean QTc(D) value at screening >430msec. the QTc(D) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 120 - 210 msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave)
Description

3. QTC interval | Electrocardiography | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0489625
UMLS CUI [2]
C1623258
UMLS CUI [3]
C0429087
UMLS CUI [4]
C1287082
UMLS CUI [5]
C0438167
4. A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg at screening
Description

4. A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg at screening

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205250
5. A mean heart rate outside the range 40 - 90 bpm at screening.
Description

5. A mean heart rate outside the range 40 - 90 bpm at screening.

Data type

boolean

Alias
UMLS CUI [1]
C0018810
6. History of use of tobacco or nicotine containing products within 6 months of screening, or positive urine cotinine at screening.
Description

6. History of use of tobacco or nicotine containing products within 6 months of screening, or positive urine cotinine at screening.

Data type

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
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0005794
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0205435
UMLS CUI [3]
C0444496
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.
Description

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.

Data type

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
9. The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications within 48 hours prior to dosing, unless it is judged by the Investigator not to comprimise their safety or influence the outcome of the study
Description

9. Take prescription medications | Before; Dosage | Drugs, Non-Prescription | Safety Issue | Affecting; research results

Data type

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
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
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C2348568
11. The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if tested according to site GOP's)
Description

11. The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if tested according to site GOP's)

Data type

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2]
C0149709
UMLS CUI [3]
C0019682
12. The subject has a positive drugs-of-abuse test
Description

12. The subject has a positive drugs-of-abuse test

Data type

boolean

Alias
UMLS CUI [1,1]
C0373483
UMLS CUI [1,2]
C1514241
13. The subjet has a positive alcohol urine test, including ethanol
Description

Note: The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study

Data type

boolean

Alias
UMLS CUI [1,1]
C2188602
UMLS CUI [1,2]
C1514241
14. The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
Description

14. The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.

Data type

boolean

Alias
UMLS CUI [1]
C0085762
15. The subject is unable to use the DISKUS™ and HandiHaler devices correctly
Description

15. The subject is unable to use the DISKUS™ and HandiHaler devices correctly

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0021461
UMLS CUI [1,3]
C1553480
16. The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethismography)
Description

16. The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethismography)

Data type

boolean

Alias
UMLS CUI [1]
C0008909
UMLS CUI [2]
C0032221
17. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of it's derivates.
Description

17. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of it's derivates.

Data type

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
18. The subject has a known allergy or hypersensitivity to the excipient lactose monohydrate.
Description

18. The subject has a known allergy or hypersensitivity to the excipient lactose monohydrate.

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1658042
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Similar models

Eligibility Question

1 forms
  1. StudyEvent: ODM
    1. Eligibility Question
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
1. Healthy male subjects
Item
1. Healthy male subjects
boolean
C1708335 (UMLS CUI [1,1])
C0079399 (UMLS CUI [1,2])
2. Aged between 18 - 50 years
Item
2. Aged between 18 - 50 years
boolean
C0001779 (UMLS CUI [1])
3. Non-smokers (never smoked or not smoking >6 month with <10 pack years history)
Item
3. Non-smokers (never smoked or not smoking >6 month with <10 pack years history)
boolean
C0337672 (UMLS CUI [1])
C1519384 (UMLS CUI [2,1])
C1277691 (UMLS CUI [2,2])
4. Normal spirometry (FEV1 >=80% of predicted, FEV1/FVC >= 70%)
Item
4. Normal spirometry (FEV1 >=80% of predicted, FEV1/FVC >= 70%)
boolean
C0037981 (UMLS CUI [1])
C0429706 (UMLS CUI [2])
C0730560 (UMLS CUI [3])
5. A signed and dated written informed consent is obtained from the subject
Item
5. A signed and dated written informed consent is obtained from the subject
text
C0021430 (UMLS CUI [1])
6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Item
6. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1,1])
C0525058 (UMLS CUI [1,2])
7. Available to complete the study.
Item
7. Available to complete the study.
boolean
C0470187 (UMLS CUI [1,1])
C2348577 (UMLS CUI [1,2])
8. Body mass index within the range 18.0 to 34.9 kg/m2
Item
8. Body mass index within the range 18.0 to 34.9 kg/m2
boolean
C1305855 (UMLS CUI [1])
9. Response to Ipratropium bromide defined as
Item
9. Response to Ipratropium bromide defined as an increase in sGaw of >= 25% over pre-dose baseline at 2 h following 80ug ipratropium bromide; or a documented increase in sGaw of >= 25% over pre-dose baseline at 2h following of 80ug of ipratropium bromide within 3 month of screening
boolean
C0700580 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
C0442805 (UMLS CUI [2])
C0439565 (UMLS CUI [3,1])
C1442488 (UMLS CUI [3,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
1. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/ medical history), clinical laboratory tests, or ECG (12-Lead or Holter)
Item
1. Any clinically relevant abnormality identified at the screening medical assessment (physical examination/ medical history), clinical laboratory tests, or ECG (12-Lead or Holter)
boolean
C1704258 (UMLS CUI [1,1])
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])
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.
Item
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.
boolean
C0262926 (UMLS CUI [1,1])
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])
3. QTC interval | Electrocardiography | Electrocardiogram: P-R interval | QT interval - finding | EKG: T wave abnormal
Item
3. A mean QTc(D) value at screening >430msec. the QTc(D) of the 3 screening ECGs are not within 10% of the mean, a PR interval outside the range 120 - 210 msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave)
boolean
C0489625 (UMLS CUI [1])
C1623258 (UMLS CUI [2])
C0429087 (UMLS CUI [3])
C1287082 (UMLS CUI [4])
C0438167 (UMLS CUI [5])
4. A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg at screening
Item
4. A history of elevated supine blood pressure or a mean blood pressure equal to or higher than 160/95 mmHg at screening
boolean
C0005823 (UMLS CUI [1,1])
C0205250 (UMLS CUI [1,2])
5. A mean heart rate outside the range 40 - 90 bpm at screening.
Item
5. A mean heart rate outside the range 40 - 90 bpm at screening.
boolean
C0018810 (UMLS CUI [1])
6. History of use of tobacco or nicotine containing products within 6 months of screening, or positive urine cotinine at screening.
Item
6. History of use of tobacco or nicotine containing products within 6 months of screening, or positive urine cotinine at screening.
boolean
C0841002 (UMLS CUI [1])
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])
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
Item
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
boolean
C0005794 (UMLS CUI [1])
C0178602 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
C0444496 (UMLS CUI [3])
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.
Item
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.
boolean
C0013227 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0278329 (UMLS CUI [2])
C0042890 (UMLS CUI [3])
C0025125 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
9. Take prescription medications | Before; Dosage | Drugs, Non-Prescription | Safety Issue | Affecting; research results
Item
9. The subject has taken: prescription medications within the past 2 weeks prior to dosing, or OTC medications within 48 hours prior to dosing, unless it is judged by the Investigator not to comprimise their safety or influence the outcome of the study
boolean
C3843193 (UMLS CUI [1])
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])
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
Item
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
boolean
C2348568 (UMLS CUI [1])
11. The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if tested according to site GOP's)
Item
11. The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if tested according to site GOP's)
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C0019682 (UMLS CUI [3])
12. The subject has a positive drugs-of-abuse test
Item
12. The subject has a positive drugs-of-abuse test
boolean
C0373483 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
13. The subjet has a positive alcohol urine test, including ethanol
Item
13. The subjet has a positive alcohol urine test, including ethanol
boolean
C2188602 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
14. The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
Item
14. The subject has a suspected history of alcohol abuse within the six months previous to the screening visit.
boolean
C0085762 (UMLS CUI [1])
15. The subject is unable to use the DISKUS™ and HandiHaler devices correctly
Item
15. The subject is unable to use the DISKUS™ and HandiHaler devices correctly
boolean
C1524063 (UMLS CUI [1,1])
C0021461 (UMLS CUI [1,2])
C1553480 (UMLS CUI [1,3])
16. The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethismography)
Item
16. The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethismography)
boolean
C0008909 (UMLS CUI [1])
C0032221 (UMLS CUI [2])
17. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of it's derivates.
Item
17. The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of it's derivates.
boolean
C0020517 (UMLS CUI [1,1])
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])
18. The subject has a known allergy or hypersensitivity to the excipient lactose monohydrate.
Item
18. The subject has a known allergy or hypersensitivity to the excipient lactose monohydrate.
boolean
C0020517 (UMLS CUI [1,1])
C1658042 (UMLS CUI [1,2])
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