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GSK598809

Phase 1

Substance Dependence | Small molecule | Other |GSK plc|Last Updated: Aug 7, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials7
Total Enrollment223
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01039454Effects of the D3 Antagonist GSK598809 on Food Reward and ReinforcementPHASE1 COMPLETED 24 — — Dec 18, 2008Apr 26, 2010Jun 20, 20172 United Kingdom
NCT00887367EtOH Interaction StudyPHASE1 COMPLETED 20 — — Sep 29, 2008Dec 3, 2008Jul 18, 20171 Netherlands
NCT00728897A Healthy Volunteer Study to Investigate the Relative Bioavailability of Two Forms of GSK598809 Capsules.PHASE1 COMPLETED 16 — — Jul 2, 2008Jul 29, 2008Aug 4, 20171 United Kingdom
NCT00728052A Human Volunteer Study Investigating Single Oral Doses of GSK598809 in Otherwise Healthy SmokersPHASE1 COMPLETED 18 — — Jun 9, 2008Aug 19, 2008Aug 3, 20171 Germany
NCT00605241A Study To Assess The Effects Of A Single Dose Of GSK598809 In Modulating Nicotine RewardPHASE1 COMPLETED 29 — — Feb 25, 2008Mar 20, 2009Jul 21, 20171 United States
NCT00437840A Study To Investigate The Safety, Tolerability And Blood Levels Of GSK598809PHASE1 COMPLETED 12 — — Mar 20, 2007Jun 20, 2007Aug 7, 20171 Germany
NCT00437632Study To Investigate If Repeat Doses Of GSK598809 Are Safe And Well Tolerated And To Evaluate Blood Levels Of GSK598809PHASE1 COMPLETED 104 — — Mar 1, 2007Aug 22, 2008Jul 31, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Functional MRI: Food Processing Task, Food-Stop Signal Task, Food Stroop Task
9 weeks
Behavioural Neurocognitive Task: Visual Probe Task, Stimulus Response Compatibility Task, Pavlovian-Instrumental Task.
9 weeks
Safety and tolerability: Vital sign measurement, 12 lead ECG and telemetry, safety laboratory sampling including prolactin and lipid measurements, Barnes Akathesia Scale (BAS), Simpson-Angus Scale (SAS) and Abnormal Involuntary Movement Scale (AIMS).
Screening: BAS, SAS and AIMS (as training only), 12 lead ECG, vital signs and clinical labs. All will be measured throughout dosing day (Day 1), day 2, 3: vital signs, day 4: vital signs, clinical labs, follow up: clinical labs, vital signs, 12 lead ECG
Pharmacokinetics: breath ethanol concentrations, blood ethanol concentrations, main pharmacokinetic parameters of GSK598809 and its metabolite (GSK685249) AUC∞, Cmax, Tmax and t½.
All will be measured throughout day 1, PK blood sampling for GSK598809 and GSK685249 will also be collected on Day 2, 3 and 4.
Pharmacodynamic: saccadic eye movements, smooth pursuit eye movements, body sway, adaptive tracking, Visual Verbal Learning Test (VVLT).
Saccadic eye movement, smooth pursuit eye movements, body sway and adaptive tracking measured at set intervals between 1.5hrs pre dose to 7.5hrs post dose. VVLT administered between 0.5hrs post dose to 3.5hrs post dose.
Blood sampling over a period of 96hrs post GSK598809 dosing in the three dosing periods.
Pre-dose, 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, 8. 10, 12, 16, 24, 48. 72 and 96 hours
Safety and tolerability: Clinical labs, cardiovascular variables, vital signs, adverse events over 48 hours post dosing and at follow up. Psychological assessment and movement scales will be monitored. Blood Sampling over 48 hours.
48 hours post dose
Pharmacokinetics
through 24 hours
Safety measures: ECG, Vital Signs, Adverse Events
for 48 hours after dosing.
PK: Blood levels of GSK598809 and nicotine
for 96 hours after dosing
Safety measures: ECG, Vital Signs, Adverse Events for 48 hours after dosing. PK measures: Blood sampling for GSK598809 for upto 96hr post dose
Up to Day 39
Secondary Endpoints
Appetite VAS, Bond and Lader VAS, Distress VAS, BIS II, TFEQ, BIS/BAS, BDI-II, Body weight, Metabolic markers: plasma leptin, ghrelin, alpa MSH
9 weeks
PK endpoints: AUC, Cmax, tmax, t1/2
9 weeks
Safety and tolerability: adverse events, laboratory values, cardiovascular - blood pressure; heart rate; ECGs, movement disorders, temperature, respiratory rate, serum prolactin, GH and TSH
9 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PlaceboPLACEBO_COMPARATOR2 way cross over.
ActiveACTIVE_COMPARATOR2 Way cross over
Placebo to match GSK598809PLACEBO_COMPARATORPlacebo to match GSK598809.
Placebo to match ethanol infusionPLACEBO_COMPARATORGlucose solution to be given in the same way as ethanol.
Subjects receiving treatment sequence ABCEXPERIMENTALEligible subjects will receive treatment sequence ABC; A= 4x25 milligrams GSK598809 capsule given in fasted state, B= 100 milligrams GSK598809 capsule in given fasted state and C= 100 milligrams GSK598809 capsule given in fed state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
Subjects receiving treatment sequence ACBEXPERIMENTALEligible subjects will receive treatment sequence ACB; A= 4x25 milligrams GSK598809 capsule given in fasted state, C= 100 milligrams GSK598809 capsule given in fed state and B= 100 milligrams GSK598809 capsule in given fasted state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
Subjects receiving treatment sequence BACEXPERIMENTALEligible subjects will receive treatment sequence BAC; B= 100 milligrams GSK598809 capsule in given fasted state, A= 4x25 milligrams GSK598809 capsule given in fasted state and C= 100 milligrams GSK598809 capsule given in fed state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
Subjects receiving treatment sequence BCAEXPERIMENTALEligible subjects will receive treatment sequence BCA; B= 100 milligrams GSK598809 capsule in given fasted state, C= 100 milligrams GSK598809 capsule given in fed state and A= 4x25 milligrams GSK598809 capsule given in fasted state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
Subjects receiving treatment sequence CABEXPERIMENTALEligible subjects will receive treatment sequence CAB; C= 100 milligrams GSK598809 capsule given in fed state, A= 4x25 milligrams GSK598809 capsule given in fasted state and B= 100 milligrams GSK598809 capsule in given fasted state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
Subjects receiving treatment sequence CBAEXPERIMENTALEligible subjects will receive treatment sequence CBA; C= 100 milligrams GSK598809 capsule given in fed state, B= 100 milligrams GSK598809 capsule in given fasted state and A= 4x25 milligrams GSK598809 capsule given in fasted state. The treatment sequence will be followed by at least a 7-day wash-out period between each dose.
Subjects receiving treatment sequence ABCDEXPERIMENTALSubjects will receive treatment sequence ABCD; A= placebo, B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, and D = GSK598809 dose 3.
Subjects receiving treatment sequence BACDEXPERIMENTALSubjects will receive treatment sequence BACD; B= GSK598809 dose 1 (75 milligrams), A= placebo, C = GSK598809 dose 2 and D = GSK598809 dose 3
Subjects receiving treatment sequence BCADEXPERIMENTALSubjects will receive treatment sequence BCAD; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, A= placebo and D = GSK598809 dose 3.
Subjects receiving treatment sequence BCDAEXPERIMENTALSubjects will receive treatment sequence BCDA; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, D = GSK598809 dose 3 and A= placebo.
GSK598809OTHERDrug
Treatment Arm AEXPERIMENTALIn Arm A dosing subject will receive Placebo in Week 1, 10 milligram (mg) of GSK598809 in Week 2, 25 mg of GSK598809 in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose.
Treatment Arm BEXPERIMENTALIn Arm B dosing subject will receive 10 mg of GSK598809 in Week 1, Placebo in Week 2, 25 mg of GSK598809 in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose.
Treatment Arm CEXPERIMENTALIn Arm C dosing subject will receive 10 mg of GSK598809 in Week 1, 25 mg of GSK598809 in Week 2, Placebo in Week 3, 75 mg of GSK598809 in Week 4. Subjects will have a wash-out of period of one week before receiving another dose.
Treatment Arm DEXPERIMENTALIn Arm D dosing subject will receive 10 mg of GSK598809 in Week 1, 25 mg of GSK598809 in Week 2, 75 mg of GSK598809 in Week 3, Placebo in Week 4. Subjects will have a wash-out of period of one week before receiving another dose.
Subjects in Cohort-1 of Section 1EXPERIMENTALSubjects will be randomized to receive either GSK598809 10 mg or Placebo.
Subjects in Cohort-2 of Section 1EXPERIMENTALSubjects will be randomized to receive either GSK598809 25 mg or Placebo.
Subjects in Cohort-3 of Section 1EXPERIMENTALSubjects will be randomized to receive either GSK598809 25 mg or Placebo.
Subjects in Cohort-4 of Section 1EXPERIMENTALSubjects will be randomized to receive either GSK598809 40 mg or Placebo.
Subjects in Cohort-5 of Section 2EXPERIMENTALSubjects will be randomized to receive either ascending doses of GSK598809 75, 120 and 175 mg or Placebo. There will be a washout period of 6 days between the doses.
Subjects in Cohort-6 of Section 3EXPERIMENTALSubjects will receive caffeine on day -1 and after randomization subject will either receive GSK598809 or Placebo on Day 1. After washout period of 1-week subject will either receive GSK598809 or Placebo for 28 days.
Interventions
NameTypeDescription
GSK598809 CapsulesDRUGGSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders.
GSK598809 Placebo CapsulesDRUGTreatment of substance dependence and potentially other impulse control disorders.
GSK598809DRUGTwo 175 mg doses of GSK598809 will be given.
EthanolOTHERA constant ethanol level of 0.6 g·L-1 for five hours will be given to the subjects intravenously. This level shows significant CNS effects, without causing too many inadvertent events. Furthermore this level is considered safe as it is just above the legal driving limit in the Netherlands (i.e. 0.5 g·L-1) and these levels are routinely achieved during social drinking. Moreover, this level leaves enough room for CNS-impairment without compromising safety, in case of a (supra-) addictive drug-alcohol interaction.
GSK598809 new formulationDRUGGSK598809 new formulation will be available as an immediate release capsule with a single dose of 100 milligrams, administered orally with 240 milliliters of water.
GSK598809 old formulationDRUGGSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water.
PlaceboDRUGPlacebo capsules will be administered orally with water.
CaffeineDRUGCaffeine 100 mg will be available as oral solution or tablet and subjects will receive Caffeine 100 mg orally on -1 day. On Day 35 caffeine and GSK598809 will be co-administered.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * generally healthy * right handed * binge eating episode * use appropriate contraception method * willing to see a dietician * overweight or obese (BMI 27 - 40 kg/m2) Exclusion Criteria: * pregnant or breast feeding female * recent weight loss or gain * recent use of weight l...

Countries:United KingdomNetherlandsGermanyUnited States
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