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Also known as GSK598809 Capsules, GSK598809 new formulation
GSK598809 · 7 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | 2 way cross over. |
| Active | ACTIVE_COMPARATOR | 2 Way cross over |
| Placebo to match GSK598809 | PLACEBO_COMPARATOR | Placebo to match GSK598809. |
| Placebo to match ethanol infusion | PLACEBO_COMPARATOR | Glucose solution to be given in the same way as ethanol. |
| Subjects receiving treatment sequence ABC | EXPERIMENTAL | Eligible 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 ACB | EXPERIMENTAL | Eligible 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 BAC | EXPERIMENTAL | Eligible 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 BCA | EXPERIMENTAL | Eligible 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 CAB | EXPERIMENTAL | Eligible 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 CBA | EXPERIMENTAL | Eligible 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 ABCD | EXPERIMENTAL | Subjects 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 BACD | EXPERIMENTAL | Subjects 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 BCAD | EXPERIMENTAL | Subjects 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 BCDA | EXPERIMENTAL | Subjects will receive treatment sequence BCDA; B= GSK598809 dose 1 (75 milligrams), C = GSK598809 dose 2, D = GSK598809 dose 3 and A= placebo. |
| GSK598809 | OTHER | Drug |
| Treatment Arm A | EXPERIMENTAL | In 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 B | EXPERIMENTAL | In 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 C | EXPERIMENTAL | In 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 D | EXPERIMENTAL | In 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 1 | EXPERIMENTAL | Subjects will be randomized to receive either GSK598809 10 mg or Placebo. |
| Subjects in Cohort-2 of Section 1 | EXPERIMENTAL | Subjects will be randomized to receive either GSK598809 25 mg or Placebo. |
| Subjects in Cohort-3 of Section 1 | EXPERIMENTAL | Subjects will be randomized to receive either GSK598809 25 mg or Placebo. |
| Subjects in Cohort-4 of Section 1 | EXPERIMENTAL | Subjects will be randomized to receive either GSK598809 40 mg or Placebo. |
| Subjects in Cohort-5 of Section 2 | EXPERIMENTAL | Subjects 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 3 | EXPERIMENTAL | Subjects 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. |
| Name | Type | Description |
|---|---|---|
| GSK598809 Capsules | DRUG | GSK598809 is being developed for the treatment of substance dependence and potentially other impulse control disorders. |
| GSK598809 Placebo Capsules | DRUG | Treatment of substance dependence and potentially other impulse control disorders. |
| GSK598809 | DRUG | Two 175 mg doses of GSK598809 will be given. |
| Ethanol | OTHER | A 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 formulation | DRUG | GSK598809 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 formulation | DRUG | GSK598809 old formulation will be available as an immediate release capsule with a single dose of 25 milligrams, administered orally with 240 milliliters of water. |
| Placebo | DRUG | Placebo capsules will be administered orally with water. |
| Caffeine | DRUG | Caffeine 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. |
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...
GSK598809 is an investigational small molecule developed by GSK plc for substance dependence. It has been studied in Phase 1 clinical trials, including research on food reward and reinforcement, ethanol interaction, and dosing in otherwise healthy smokers. All seven of its trials are completed, with no active studies ongoing.
GSK598809 has been studied for substance dependence, a psychiatry indication. Its Phase 1 trials explored effects on food reward and reinforcement, ethanol interaction, and single oral doses in otherwise healthy smokers. It is investigational and has not been approved for any use.
GSK598809 is developed by GSK plc, which trades under the ticker GSK. The company sponsored the Phase 1 clinical program evaluating the compound in substance dependence and related healthy volunteer studies.
GSK598809 is in Phase 1 clinical development. All seven of its trials are completed, and none are currently active. It is an investigational small molecule and has not been approved by the FDA or any other regulatory agency for substance dependence or any other indication.
Completed Phase 1 trials of GSK598809 include NCT01039454, which examined effects on food reward and reinforcement in 24 participants in the United Kingdom, NCT00887367, an ethanol interaction study in 20 participants in the Netherlands, NCT00728897, a relative bioavailability study of two capsule forms in 16 participants, and NCT00728052, a single oral dose study in 18 healthy smokers in Germany.