Male or female between the ages of 18 and 64, inclusive, at the time of signing the informed consent.
boolean
C0079399 (UMLS CUI [1]) C0001779 (UMLS CUI [2])
Childbearing Potential
Item
A female subject is eligible to participate of she is of non-childbearing potential - see protocol for definition of non-childbearing potential.
boolean
C3831118 (UMLS CUI [1])
Contraceptive methods
Item
Male 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 months after the final dose.
boolean
C0700589 (UMLS CUI [1])
Health Status
Item
Healthy as determined by a responsible and experienced physician, based on a medical valuation including medical history, physical examination, laboratory tests and cardiac monitoring.
boolean
C0018759 (UMLS CUI [1])
Body mass index; Body Weight
Item
Body mass index 19 - 29.9 kg/m2 (inclusive), body weight >50 kg for males and >45 kg for females, who are not morbidly obese.
boolean
C1305855 (UMLS CUI [1]) C0005910 (UMLS CUI [2])
Informed Consent; Protocol Compliance
Item
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
boolean
C0021430 (UMLS CUI [1]) C0525058 (UMLS CUI [2])
English Language
Item
Capable of reading, comprehending and writing English at a sufficient level to complete study-related materials.
Subjects must have AST, ALT, alkaline phosphatase and bilirubin <1.5xULN
boolean
C0201899 (UMLS CUI [1]) C0201836 (UMLS CUI [2]) C0201850 (UMLS CUI [3]) C0344395 (UMLS CUI [4])
QTc interval
Item
Subjects must have QTc values within the normal range, i.e. QTcF < 450 msec.
boolean
C0489625 (UMLS CUI [1])
Vital signs
Item
Subjects must have normal vital signs in standing and semi-supine position. Guideline normal ranges are systolic BP 90-140, diastolic BP 60-90, heart rate 50-90.
Current or past diagnosis of psychiatric disorder, as assessed by the MINI.
boolean
C0004936 (UMLS CUI [1])
At risk for suicide
Item
Subjects, who in the investigator's judgement, pose a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior and/or suicidal ideation of type 4 or 5 on the C-SSRS in the last 6 months.
boolean
C0563664 (UMLS CUI [1])
Cardiovascular Diseases
Item
Current of past diagnosis of cardiovascular disease including but not limited to hypertension, cardiac arrhythmias and/or risk factors for coronary artery disease.
boolean
C0007222 (UMLS CUI [1])
Long QT Syndrome; Cardiac conduction abnormality; Heart Diseases
Item
Personal or family history of long QT syndrome, cardiac conduction disorder or other clinically significant cardiac disease.
boolean
C0023976 (UMLS CUI [1]) C1842820 (UMLS CUI [2]) C0018799 (UMLS CUI [3])
Cerebrovascular Disorders
Item
Current or past diagnosis of a cerebrovascular disease (e.g., stroke, transient ischemic attacks, aneurysms).
boolean
C0007820 (UMLS CUI [1])
Autonomic nervous system, Dysfunction
Item
Current or past diagnosis of autonomic dysfunction (e.g. prone to fainting, orthostatic hypotension, sinus arrhythmia).
boolean
C0004388 (UMLS CUI [1,1]) C3887504 (UMLS CUI [1,2])
Respiration Disorders
Item
Current or past diagnosis of acute or chronic respiratory disease (including asthma and chronic obstructive pulmonary disease)
boolean
C0035204 (UMLS CUI [1])
Kidney Diseases
Item
Current or past diagnosis of acute or chronic renal disease.
boolean
C0022658 (UMLS CUI [1])
Laboratory Procedures, Renal function
Item
Subjects with renal monitoring test values outside of the ranges in Appendix 3. Renal monitoring tests may be repeated once if value(s) are abnormal but such abnormality must have normalized by the baseline visit.
boolean
C0022885 (UMLS CUI [1,1]) C0232804 (UMLS CUI [1,2])
Gastrointestinal Hemorrhage; Peptic Ulcer; Gastrointestinal Diseases, Active
Item
Subjects with a history of gastrointestinal bleeding and/or a history of peptic ulcer disease and/or presence of active gastrointestinal disease.
boolean
C0017181 (UMLS CUI [1]) C0030920 (UMLS CUI [2]) C0017178 (UMLS CUI [3,1]) C0205177 (UMLS CUI [3,2])
Liver diseases; Abnormality of the liver; Biliary tract abnormality
Item
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
boolean
C0023895 (UMLS CUI [1]) C4021780 (UMLS CUI [2]) C0549613 (UMLS CUI [3])
Disease, Study Subject Participation Status
Item
Subjects with an unstable medical disorder or a disorder (including surgical interventions) that would likely interfere with the action, absorption, distribution, metabolism or excretion of GSK1034702, may pose a safety concern, or interfere with accurate assessment of safety.
boolean
C0012634 (UMLS CUI [1,1]) C2348568 (UMLS CUI [1,2])
Hepatitis B surface antigen positive; Hepatitis C antibody positive
Item
A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
boolean
C0149709 (UMLS CUI [1]) C0281863 (UMLS CUI [2])
HIV antibody positive
Item
A positive test for HIV antibody.
boolean
C0920548 (UMLS CUI [1])
Drug abuse; Alcohol abuse
Item
Drug or alcohol abuse within the 12 months prior to dosing.
boolean
C0013146 (UMLS CUI [1]) C0085762 (UMLS CUI [2])
Drug screen (procedure); Blood alcohol test positive
Item
A positive pre-study drug/alcohol screen.
boolean
C0373483 (UMLS CUI [1]) C0948726 (UMLS CUI [2])
Alcohol consumption
Item
History of regular alcohol consumption within 6 months of the study defined as: • an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
boolean
C0001948 (UMLS CUI [1])
Tobacco use
Item
Subject is a smoker.
text
C0543414 (UMLS CUI [1])
Pharmaceutical Preparations
Item
Use of prescription or non-prescription drugs including vitamins, herbal and dietary supplements (including St John’s Wort) within 4 weeks 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
C0013227 (UMLS CUI [1])
Red wine; Citrus aurantium; Grapefruit (food); GRAPEFRUIT JUICE
Item
Consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to the first dose of study medication.
boolean
C0349371 (UMLS CUI [1]) C0330922 (UMLS CUI [2]) C0995150 (UMLS CUI [3]) C0452456 (UMLS CUI [4])
Experimental drug, Hypersensitivity
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
C0304229 (UMLS CUI [1,1]) C0020517 (UMLS CUI [1,2])
Dextromethorphan, Hypersensitivity
Item
Hypersensitivity to any of the ingredients of dextromethorphan.
boolean
C0011816 (UMLS CUI [1,1]) C0020517 (UMLS CUI [1,2])
Study Subject Participation Status
Item
The subject has participated in a clinical trial and has received an investigational product 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 investigational product (whichever is longer).
boolean
C2348568 (UMLS CUI [1])
Pharmaceutical Preparations, New
Item
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
boolean
C0013227 (UMLS CUI [1,1]) C0205314 (UMLS CUI [1,2])
Blood Donation
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])
Protocol Compliance
Item
Unwillingness or inability to follow the procedures outlined in the protocol.
boolean
C0525058 (UMLS CUI [1])
Mental handicap; legal capacity, Lacking
Item
Subject is mentally or legally incapacitated.
boolean
C1306341 (UMLS CUI [1]) C0683673 (UMLS CUI [2,1]) C0332268 (UMLS CUI [2,2])