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])
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])
Drugs, Non-Prescription; Prescription Drugs | Vitamins | Herbal Supplements | Dietary Supplements | ST. JOHN'S WORT EXTRACT | Enzymes; Inducer | Before; Administration of medication | Study; Procedure (set of actions) | patient safety
Item
Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half- lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
boolean
C0013231 (UMLS CUI [1,1])
C0304227 (UMLS CUI [1,2])
C0042890 (UMLS CUI [2])
C1504473 (UMLS CUI [3])
C0242295 (UMLS CUI [4])
C0813171 (UMLS CUI [5])
C0014442 (UMLS CUI [6,1])
C3898767 (UMLS CUI [6,2])
C0332152 (UMLS CUI [7,1])
C3469597 (UMLS CUI [7,2])
C2603343 (UMLS CUI [8,1])
C2700391 (UMLS CUI [8,2])
C1113679 (UMLS CUI [9])
Broccoli - dietary | Radish (Vegetable) | Cauliflower (dietary) | Cabbage - dietary | Orange juice | Apple juice | GRAPEFRUIT JUICE | Grapefruit (food) | Before; Administration of medication | Collection of blood specimen for laboratory procedure; Pharmacokinetic aspects
Item
Consumption of broccoli, radish sprouts, cauliflower, cabbage, orange juice, apple juice, grapefruit juice or grapefruit within 7 days prior to the first dose of study medication until collection of the final pharmacokinetic blood sample.
boolean
C0330499 (UMLS CUI [1])
C0446300 (UMLS CUI [2])
C0446302 (UMLS CUI [3])
C0006619 (UMLS CUI [4])
C0452458 (UMLS CUI [5])
C0452454 (UMLS CUI [6])
C0452456 (UMLS CUI [7])
C0995150 (UMLS CUI [8])
C0332152 (UMLS CUI [9,1])
C3469597 (UMLS CUI [9,2])
C0005834 (UMLS CUI [10,1])
C0031328 (UMLS CUI [10,2])
Study Subject Participation Status | Experimental drug; Before; Administration of medication
Item
The subject has participated in a clinical trial and has received an investigational product (IP) within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the IP (whichever is longer).
boolean
C2348568 (UMLS CUI [1])
C0304229 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C3469597 (UMLS CUI [2,3])
Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.
Item
Exposure to more than four new chemical entities (i.e., medical drugs being under development) within 12 months prior to the first dosing day.
boolean
C0332157 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0220806 (UMLS CUI [1,3])
C0332152 (UMLS CUI [1,4])
C0205435 (UMLS CUI [1,5])
C0439228 (UMLS CUI [1,6])
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
Item
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
boolean
C0005794 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
Unwillingness or inability to follow the procedures outlined in the protocol.
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C1299582 (UMLS CUI [2,1])
C0525058 (UMLS CUI [2,2])
The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
Item
The subject is unable or unwilling to abstain from strenuous physical activity in the 48 h before screening and up to the follow up visit.
boolean
C1514989 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1514989 (UMLS CUI [2,1])
C3843422 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C0220908 (UMLS CUI [3,2])
C0589121 (UMLS CUI [4])
Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
Item
Subject is the investigator or his/her deputies, research assistant, pharmacist, study coordinator, other staff or relative thereof involved in the conduct of the study.
boolean
C0027361 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C0035173 (UMLS CUI [1,4])
C0080103 (UMLS CUI [1,5])