Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK958108 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| GSK958108 3 mg | EXPERIMENTAL | Experimental |
| Placebo of GSK958108 | PLACEBO_COMPARATOR | Placebo |
| Subjects receiving GSK958108 + placebo in cohort 1 | EXPERIMENTAL | Eligible subjects will receive GSK958108 with a starting dose of 1 milligram. The dose escalation will be continued up to 4 ascending doses. Subjects will also receive placebo. Each treatment period will be separated by at least 7 days washout period. |
| Subjects receiving GSK958108 + placebo in cohort 2 | EXPERIMENTAL | Eligible subjects will start dosing once the cohort 1 has completed the treatment phase and the initial dose will be the same as top dose in Cohort1.The dose escalation will be continued up to 4 ascending doses. Subjects will also receive placebo. Each treatment period will be separated by at least 7 days washout period. |
| Name | Type | Description |
|---|---|---|
| GSK958108 | DRUG | Coated Tablets 1 mg |
| Placebo | DRUG | Coated tablets |
Inclusion Criteria: * Heterosexual male subject with self-reported moderate or severe primary Premature ejaculation with ejaculation occurring on or before penetration, or shortly there after with minimal stimulation * Baseline Ejaculation Latency time \< 3 minutes * Subjects must agree to use a co...
GSK958108 is an investigational small molecule being developed for the treatment of premature ejaculation. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
GSK958108 is being developed by GSK plc, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK.
GSK958108 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and the drug remains investigational, meaning it has not received regulatory approval.
GSK958108 has been studied in two completed Phase 1 trials. The first, NCT00664365, was a first-time-in-human study conducted in the United Kingdom with 21 participants. The second, NCT00861484, was a proof-of-mechanism study in Italy with 33 participants.
No alternative names for GSK958108 have been disclosed. It is identified solely by its compound number in clinical trial registries and scientific literature.