ID

38928

Beschreibung

Study ID: 109652 Clinical Study ID: 109652 Study Title: A Single-centre Open Label Study to Investigate the Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin in Healthy Male Volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01299597 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: SB649868 Trade Name: Atorvastatin, Simvastatin Study Indication: Sleep Disorders

Stichworte

  1. 13.11.19 13.11.19 -
  2. 15.11.19 15.11.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

13. November 2019

DOI

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Creative Commons BY-NC 3.0

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Effect of Repeat Doses of SB-649868 on the Pharmacokinetics of Simvastatin and Atorvastatin NCT01299597

Screening - Eligibility Criteria

Administrative
Beschreibung

Administrative

Alias
UMLS CUI-1
C1320722
Subject Identifier
Beschreibung

Subject Identifier

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Eligibility Question
Beschreibung

Eligibility Question

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

Did the subject meet all the entry criteria?

Datentyp

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Healthy male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, neuropsychiatric status using the MINI International Neuropsychiatric Interview, laboratory tests and cardiac monitoring.
Beschreibung

A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. However, • Subjects with cTpn I values above 99th percentile of normal range of the selected assay should always be excluded from enrollment; • Subjects with alkaline phosphatase or bilirubin >1.5xULN should always be excluded (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%);

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C3898900
UMLS CUI [2]
C0031831
UMLS CUI [3]
C0220825
UMLS CUI [4]
C0031809
UMLS CUI [5]
C4505426
UMLS CUI [6]
C0022885
UMLS CUI [7]
C0150496
Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Beschreibung

Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
UMLS CUI [2]
C0021430
Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
Beschreibung

Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.

Datentyp

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
Subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 days post last dose (equivalent to 5 terminal half-lives post-last dose).
Beschreibung

Contraceptive methods; Date treatment or therapy started; Date last dose

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C3173309
UMLS CUI [1,3]
C1762893
Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Beschreibung

Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0525058
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
History or presence of significant psychiatric neurological, musculo-skeletal , respiratory, gastrointestinal, hepatic, uncontrolled hypothyroidism, pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Beschreibung

Neuropsychiatric syndrome | Musculoskeletal System; Disease | Respiration Disorders | Gastrointestinal Diseases | Liver diseases | Hypothyroidism; Uncontrolled | Pancreatic Diseases | Kidney Diseases | Disease; Interferes with; Absorption, Physiological | Disease; Interferes with; Distribution | Disease; Interferes with; Metabolism | Disease; Interferes with; Excretory function

Datentyp

boolean

Alias
UMLS CUI [1]
C3203509
UMLS CUI [2,1]
C0026860
UMLS CUI [2,2]
C0012634
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0017178
UMLS CUI [5]
C0023895
UMLS CUI [6,1]
C0020676
UMLS CUI [6,2]
C0205318
UMLS CUI [7]
C0030286
UMLS CUI [8]
C0022658
UMLS CUI [9,1]
C0012634
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C0237442
UMLS CUI [10,1]
C0012634
UMLS CUI [10,2]
C0521102
UMLS CUI [10,3]
C1704711
UMLS CUI [11,1]
C0012634
UMLS CUI [11,2]
C0521102
UMLS CUI [11,3]
C0025519
UMLS CUI [12,1]
C0012634
UMLS CUI [12,2]
C0521102
UMLS CUI [12,3]
C0221102
Subjects, who in the Investigator’s judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
Beschreibung

At risk for suicide | Suicidal behavior | Feeling suicidal (finding); C-SSRS Since Last Visit - Ideation With Plan/Intent

Datentyp

boolean

Alias
UMLS CUI [1]
C0563664
UMLS CUI [2]
C1760428
UMLS CUI [3,1]
C0424000
UMLS CUI [3,2]
C3641607
History of cardiovascular diseases and/or evidence of repolarization defects.
Beschreibung

History of cardiovascular diseases and/or evidence of repolarization defects.

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0948857
Family history of heriditary muscular disorders.
Beschreibung

Family history of heriditary muscular disorders.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0026848
UMLS CUI [1,2]
C0439660
Subjects with abnormal ECG defined as: average QTcB or QTcF > 450 msec; PQ < 120 ms or > 220 ms; complete left bundle branch block; second-or third-degree AV block; any relevant ST/T wave abnormalities ; any atrial or ventricular arrhtymias which are of clinical significance as determined by the Investigator.
Beschreibung

Electrocardiogram abnormal | QTcB - Bazett's Correction Formula | QTcF - Fridericia's Correction Formula | Electrocardiogram PQ interval | Left Bundle-Branch Block | Second degree atrioventricular block | EKG: T wave abnormal | EKG ST segment changes | Atrial Fibrillation; Atrial Flutter | Ventricular arrhythmia

Datentyp

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2]
C1882512
UMLS CUI [3]
C1882513
UMLS CUI [4]
C1167690
UMLS CUI [5]
C0023211
UMLS CUI [6]
C0264906
UMLS CUI [7]
C0438167
UMLS CUI [8]
C0232326
UMLS CUI [9,1]
C0004238
UMLS CUI [9,2]
C0004239
UMLS CUI [10]
C0085612
History of regular alcohol consumption within 6 months of the study
Beschreibung

Defined as: • an average weekly intake of greater than 21 units (14 units for female) or an average daily intake of greater than 3 units (2 units for female). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001948
UMLS CUI [1,2]
C0205272
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.
Beschreibung

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.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0304229
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0304229
UMLS CUI [2,3]
C1705248
UMLS CUI [3]
C0013182
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0205394
Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
Beschreibung

Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.

Datentyp

boolean

Alias
UMLS CUI [1]
C0949366
UMLS CUI [2]
C1306341
UMLS CUI [3]
C0683673
UMLS CUI [4]
C0237167
UMLS CUI [5]
C0392337
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Beschreibung

A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening

Datentyp

boolean

Alias
UMLS CUI [1]
C0019168
UMLS CUI [2]
C0281863
A positive test for HIV antibody.
Beschreibung

A positive test for HIV antibody.

Datentyp

boolean

Alias
UMLS CUI [1]
C0920548
A positive pre-study drug/alcohol screen.
Beschreibung

A positive pre-study drug/alcohol screen.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0743295
UMLS CUI [1,2]
C1527048
UMLS CUI [2,1]
C0948726
UMLS CUI [2,2]
C1527048
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
Beschreibung

Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1697737
UMLS CUI [1,2]
C0543414

Ähnliche Modelle

Screening - Eligibility Criteria

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
Gender; Healthy | Physicians | Evaluation | Physical Examination |Mini International Neuropsychiatric Interview | Laboratory Procedures | Cardiac monitoring
Item
Healthy male subject, as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, neuropsychiatric status using the MINI International Neuropsychiatric Interview, laboratory tests and cardiac monitoring.
boolean
C0079399 (UMLS CUI [1,1])
C3898900 (UMLS CUI [1,2])
C0031831 (UMLS CUI [2])
C0220825 (UMLS CUI [3])
C0031809 (UMLS CUI [4])
C4505426 (UMLS CUI [5])
C0022885 (UMLS CUI [6])
C0150496 (UMLS CUI [7])
Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Item
Male between 18 and 65 years of age inclusive, at the time of signing the informed consent.
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
Item
Body weight 50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive.
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Contraceptive methods; Date treatment or therapy started; Date last dose
Item
Subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 days post last dose (equivalent to 5 terminal half-lives post-last dose).
boolean
C0700589 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])
C1762893 (UMLS CUI [1,3])
Having given written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Item
Having given written 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])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Neuropsychiatric syndrome | Musculoskeletal System; Disease | Respiration Disorders | Gastrointestinal Diseases | Liver diseases | Hypothyroidism; Uncontrolled | Pancreatic Diseases | Kidney Diseases | Disease; Interferes with; Absorption, Physiological | Disease; Interferes with; Distribution | Disease; Interferes with; Metabolism | Disease; Interferes with; Excretory function
Item
History or presence of significant psychiatric neurological, musculo-skeletal , respiratory, gastrointestinal, hepatic, uncontrolled hypothyroidism, pancreatic or renal diseases or of any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
boolean
C3203509 (UMLS CUI [1])
C0026860 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0035204 (UMLS CUI [3])
C0017178 (UMLS CUI [4])
C0023895 (UMLS CUI [5])
C0020676 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C0030286 (UMLS CUI [7])
C0022658 (UMLS CUI [8])
C0012634 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C0237442 (UMLS CUI [9,3])
C0012634 (UMLS CUI [10,1])
C0521102 (UMLS CUI [10,2])
C1704711 (UMLS CUI [10,3])
C0012634 (UMLS CUI [11,1])
C0521102 (UMLS CUI [11,2])
C0025519 (UMLS CUI [11,3])
C0012634 (UMLS CUI [12,1])
C0521102 (UMLS CUI [12,2])
C0221102 (UMLS CUI [12,3])
At risk for suicide | Suicidal behavior | Feeling suicidal (finding); C-SSRS Since Last Visit - Ideation With Plan/Intent
Item
Subjects, who in the Investigator’s judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
boolean
C0563664 (UMLS CUI [1])
C1760428 (UMLS CUI [2])
C0424000 (UMLS CUI [3,1])
C3641607 (UMLS CUI [3,2])
History of cardiovascular diseases and/or evidence of repolarization defects.
Item
History of cardiovascular diseases and/or evidence of repolarization defects.
boolean
C0007222 (UMLS CUI [1])
C0948857 (UMLS CUI [2])
Family history of heriditary muscular disorders.
Item
Family history of heriditary muscular disorders.
boolean
C0026848 (UMLS CUI [1,1])
C0439660 (UMLS CUI [1,2])
Electrocardiogram abnormal | QTcB - Bazett's Correction Formula | QTcF - Fridericia's Correction Formula | Electrocardiogram PQ interval | Left Bundle-Branch Block | Second degree atrioventricular block | EKG: T wave abnormal | EKG ST segment changes | Atrial Fibrillation; Atrial Flutter | Ventricular arrhythmia
Item
Subjects with abnormal ECG defined as: average QTcB or QTcF > 450 msec; PQ < 120 ms or > 220 ms; complete left bundle branch block; second-or third-degree AV block; any relevant ST/T wave abnormalities ; any atrial or ventricular arrhtymias which are of clinical significance as determined by the Investigator.
boolean
C0522055 (UMLS CUI [1])
C1882512 (UMLS CUI [2])
C1882513 (UMLS CUI [3])
C1167690 (UMLS CUI [4])
C0023211 (UMLS CUI [5])
C0264906 (UMLS CUI [6])
C0438167 (UMLS CUI [7])
C0232326 (UMLS CUI [8])
C0004238 (UMLS CUI [9,1])
C0004239 (UMLS CUI [9,2])
C0085612 (UMLS CUI [10])
History of regular alcohol consumption within 6 months of the study
Item
History of regular alcohol consumption within 6 months of the study
boolean
C0001948 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
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.
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.
boolean
C0020517 (UMLS CUI [1,1])
C0304229 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0304229 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
C0013182 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
Item
Vulnerable subjects, or subject is mentally or legally incapacitated, or has language barrier precluding adequate understanding of cooperation.
boolean
C0949366 (UMLS CUI [1])
C1306341 (UMLS CUI [2])
C0683673 (UMLS CUI [3])
C0237167 (UMLS CUI [4])
C0392337 (UMLS CUI [5])
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
boolean
C0019168 (UMLS CUI [1])
C0281863 (UMLS CUI [2])
A positive test for HIV antibody.
Item
A positive test for HIV antibody.
boolean
C0920548 (UMLS CUI [1])
A positive pre-study drug/alcohol screen.
Item
A positive pre-study drug/alcohol screen.
boolean
C0743295 (UMLS CUI [1,1])
C1527048 (UMLS CUI [1,2])
C0948726 (UMLS CUI [2,1])
C1527048 (UMLS CUI [2,2])
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
Item
Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine- containing products within 6 months prior to screening.
boolean
C1697737 (UMLS CUI [1,1])
C0543414 (UMLS CUI [1,2])

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