Clinical trial NCT01485185 (phase 1, status: completed)
Conditions: pain, neuropathic
ICD codes: E85.1, E85.0, N31.0, N31.1, N31.2, E10.610, E11.610
Drugs: gabapentin lower dose, donepezil, gabapentin higher dose
SMILES: CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1, O=S(=O)(C1=CC=CC=C1)C1=CN=C2C(C=CC=C2N2CCNCC2)=C1, CC(C)C(=O)OC(C)OC(=O)NCC1(CC(O)=O)CCCCC1
Eligibility criteria:

        Inclusion Criteria:

          1. Male between 18 and 55 years of age inclusive, at the time of signing the informed
             consent.

          2. Body weight ≥ 50 Kilogram (kg) and BMI within the range 18.5-29.9 Killogram per square
             meter (kg/m2) (inclusive).

          3. Healthy as determined by a responsible and experienced physician, based on a medical
             evaluation including medical history, physical examination, psychiatric history,
             psychiatric evaluation, laboratory tests and cardiac monitoring.

          4. Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), alkaline phosphatase
             and bilirubin ≤ 1.5x Upper Limit of Normal (ULN)

          5. QT duration corrected for heart rate by Bazett's formula (QTcB) or QT duration
             corrected for heart rate by Fridericia's formula (QTcF) < 450 milli second (msec).

        Exclusion Criteria:

          1. The subject has either a previous disease or current medical condition, which as
             judged by the Investigator, may compromise safety or affect the interpretation of
             efficacy data.

          2. History of known or suspected seizures, including infantile febrile, unexplained
             significant and recent loss of consciousness or history of significant head trauma
             with loss of consciousness or a family history (first degree relative) of epilepsy or
             seizures (fits).

          3. Abnormalities in 12-lead Electrocardiogram (ECG)

          4. Systolic blood pressure (BP) below 90 or above 160mm Hg, or diastolic blood pressure
             below 50 or above 100 millimeters of mercury (mmHg).

          5. History of sensitivity to any of the study medications

          6. History of regular alcohol consumption within 6 months of the study defined as: an
             average weekly intake of >21 units. One unit is equivalent to 8 g of alcohol: a
             half-pint (~240 millil litre [ml]) of beer, 1 glass (125 ml) of wine or 1 (25 ml)
             measure of spirits.

          7. A positive pre-study drug/alcohol screen at the screening visit.

          8. Excessive caffeine drinkers (~5 or more cups a day) .

          9. Excessive smokers (>5 /day)

         10. 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 screening,
             unless in the opinion of the Investigator and GSK Medical Monitor the medication will
             not interfere with the study procedures or compromise subject safety.

         11. Use of any topical steroid or capsaicin preparations in the previous 30 days to
             screening, unless in the opinion of the Investigator and GSK Medical Monitor the
             medication will not interfere with the study procedures or compromise subject safety.

         12. The subject is needle phobic

         13. The subject is unable to tolerate the electrical hyperalgesia model or nerve
             stimulation, including anxiety or atypical response to the stimulation on the training
             at the screening visit.

         14. The subject does not produce an area of allodynia or hyperalgesia to the electrical
             hyperalgesia model during the screening session.

         15. Subject who, in the investigator/designee's judgement, poses a significant suicide
             risk. Evidence of serious suicide risk may include any history of suicidal behaviour
             and/or any evidence of suicidal ideation on any questionnaires e.g. type 4 or 5 on the
             C-SSRS in the last 6 months.

         16. The subject has participated in a clinical trial and has received an investigational
             product within the following time period prior to the baseline session in the current
             study: 90 days, 5 half-lives or twice the duration of the biological effect of the
             investigational product (whichever is longer).

         17. Where participation in the study would result in donation of blood or blood products
             in excess of 500 mL within a 84 day period.

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

         19. Unwillingness or inability to follow the procedures outlined in the protocol.