Subject Screening No.
Item
Subject Screening number
integer
C0220908 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Subject Number
Item
Subject no.
integer
C2348585 (UMLS CUI [1])
Handedness, Gender, Age
Item
Right-handed healthy male subjects aged between 18 and 55 years, inclusive.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0023114 (UMLS CUI [3])
Body weight, BMI
Item
Body weight >50 kg and Body Mass Index (BMI) within the range 19–29.9 kg/m2 inclusive.
boolean
C1305855 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
Clinical Examination
Item
No abnormality on relevant clinical examination.
boolean
C0031809 (UMLS CUI [1])
Clinical Chemistry, Haematology Examination
Item
No abnormality on relevant clinical chemistry or haematology examination at the pre-study medical examination.
boolean
C0008000 (UMLS CUI [1])
C0018941 (UMLS CUI [2])
12-lead ECG
Item
A 12-lead ECG at the pre-study medical examination, which is normal.
boolean
C0430456 (UMLS CUI [1])
Informed Consent
Item
Signed and dated written informed consent prior to admission to the study
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
boolean
C0525058 (UMLS CUI [1])
EEG with Photo Stimulation
Item
Normal EEG with photo stimulation
boolean
C0430786 (UMLS CUI [1])
Pre-study HepB, HepC and HIV Antibody Test
Item
A positive pre-study Hepatitis B suface antigen, Hepatitis C antibody, and Human Immunodeficiency virus (HIV) antibody result at screening examination.
boolean
C0201487 (UMLS CUI [1])
C0201478 (UMLS CUI [2])
C2229753 (UMLS CUI [3])
Urine Drug Test
Item
A positive pre-study urine drug test at screening or prior to each treatment period
boolean
C0202274 (UMLS CUI [1])
Alcohol Urine Drug Test
Item
A positive alcohol urine drug test at screening or prior to each treatment period.
boolean
C0202304 (UMLS CUI [1,1])
C0042036 (UMLS CUI [1,2])
Unwillingness of Male Subject to Use Condom plus Femal Partner Unwilling to Use Another Form of Contraception, e.g. IUD, Diaphragm with Spermicide, Oral Contraceptives, Injectable Progesterone, Subdermal Implants or Tubal Ligation
Item
An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 30 days following administration of the last dose of study medication.
boolean
C1706180 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3873750 (UMLS CUI [1,3])
C1524063 (UMLS CUI [1,4])
C1705497 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
C0021900 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C0544374 (UMLS CUI [6])
C0375850 (UMLS CUI [7])
C0520483 (UMLS CUI [8])
History of Recent Drug or Alcohol Abuse
Item
History or evidence of drug or alcohol abuse within six months of study start.
boolean
C0262926 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0085762 (UMLS CUI [1,3])
C0262926 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0038586 (UMLS CUI [2,3])
Weekly Alcohol Intake
Item
Weekly alcohol intake of more than 21 units or an average daily intake of greater than three units.
boolean
C0001948 (UMLS CUI [1,1])
C0332174 (UMLS CUI [1,2])
Drug and Alcohol Urine Test
Item
Positive pre-study drugs of abuse or alcohol urine test
boolean
C0202274 (UMLS CUI [1,1])
C0868676 (UMLS CUI [1,2])
C0202304 (UMLS CUI [2,1])
C0042036 (UMLS CUI [2,2])
Recent Medication of Prescribed or Non-Prescribed Medication Excluding Paracetamol
Item
Has received prescribed or non-prescribed medication (including vitamins, herbal remedies and antacids) within 7 days prior to the dosing day, which in the opinion of the Principal/Co-Investigator, may interfere with the study procedures or compromise safety. Paracetamol for mild analgesia will be permitted
boolean
C0332185 (UMLS CUI [1,1])
C3166216 (UMLS CUI [1,2])
C0332185 (UMLS CUI [2,1])
C4081824 (UMLS CUI [2,2])
C0042890 (UMLS CUI [3])
C1360419 (UMLS CUI [4])
C0003138 (UMLS CUI [5])
C0000970 (UMLS CUI [6,1])
C2828389 (UMLS CUI [6,2])
Trial Participation with Investigational Drug
Item
Participation in a trial with and investigational drug within 30 days or 5 half lives (whichever is longer) prior to dosing
boolean
C2348568 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Recent Blood Donation
Item
Donation of blood in excess of 500 mL within 3 months prior to the first dose of study medication
boolean
C0005794 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
History of Hypersensitivity to Lamotrigine
Item
History of hypersensitivity to lamotrigine
boolean
C0262926 (UMLS CUI [1,1])
C0020517 (UMLS CUI [1,2])
C0064636 (UMLS CUI [1,3])
History of Skin Rashes and Allergies
Item
History of clinically relevant skin rashes and allergies that, in the opinion of the investigator, might interfere with the conduct of the study.
boolean
C0262926 (UMLS CUI [1,1])
C0015230 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0020517 (UMLS CUI [2,2])
Side Effect Affecting Professional Occupation, Operating Machinery, Driving
Item
Any subject where the potential CNS side effects of GW273225 and lamotrigine could affect their professional occupation, e.g. operating machinery, driving.
boolean
C0879626 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2698884 (UMLS CUI [1,3])
C2698884 (UMLS CUI [2])
C0004379 (UMLS CUI [3])
History of Seizure Disorder or Brain Injury, any Condition with Predisposition to Seizure, Treatment with Medications lowering Seizure Threshold or Undergoing Abrupt Discontinuation of Alcohol or Sedatives
Item
Subject has current or past history of seizure disorder or brain injury (traumatic or disease-related), or any condition which, in the opinion of the investigator, predisposes to seizure; subject treated with other medications or treatment regimens that lower seizure threshold; subject undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).
boolean
C0262926 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0876926 (UMLS CUI [2,2])
C0220898 (UMLS CUI [3,1])
C0036572 (UMLS CUI [3,2])
C0234976 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0457454 (UMLS CUI [5,1])
C0001948 (UMLS CUI [5,2])
C0457454 (UMLS CUI [6,1])
C0036557 (UMLS CUI [6,2])
Migraine Headaches Uncontrolled
Item
Poorly-controlled migraine headaches
boolean
C0149931 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Implanted metal Devices, Pacemakers
Item
Implanted metal devices including pacemakers
boolean
C0025080 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
Previous Brain Surgery
Item
Previous brain neurosurgery
boolean
C0524850 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
History of Neurological Disorders and Stroke
Item
History of neurological disorders and stroke
boolean
C0262926 (UMLS CUI [1,1])
C0027765 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0038454 (UMLS CUI [2,2])
Satisfaction of Inclusion/Exclusion Criteria
Item
Does the subject satisfy the Inclusion/Exclusion criteria of this study protocol?
boolean
C0242428 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0242428 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
Satisfaction of Inclusion/Exclusion Criteria Comment
Item
Does the subject satisfy the Inclusion/Exclusion criteria of this study protocol?
text
C0242428 (UMLS CUI [1,1])
C1512693 (UMLS CUI [1,2])
C0242428 (UMLS CUI [2,1])
C0680251 (UMLS CUI [2,2])
C0947611 (UMLS CUI [3])
Physician's Initials
Item
Physician's Initials
text
C1997894 (UMLS CUI [1,1])
C2986440 (UMLS CUI [1,2])
Date
Item
Date
date
C0011008 (UMLS CUI [1])