Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GSK557296 · 3 trials · 3 indications
Male participant needed to make a minimum of 4 attempts at SI and Baseline IELTs were assessed by stop watch measurements for each SI attempt. IELT was the elapsed time from vaginal penetration until ejaculation. On-treatment IELT for each participant was calculated by taking the median IELT from all valid on-treatment IELT attempts. Geometric mean IELT for each treatment was compared using analysis of covariance (ANCOVA). LS mean values and two-sided p-values are from the general linear model ln(median IELT)= ln(Baseline IELT) + treatment + cluster. A step-down procedure was used to determine if the efficacy of on-demand GSK557296 was superior to placebo. First, the average of the geometric mean IELTs of the pooled 150mg and 50mg doses of GSK557296 was tested against placebo, and if significance was achieved with this global plateau trend test (p \< 0.05), then the simultaneous pair wise comparisons of the 150mg and 50mg doses to placebo would occur (each at an alpha level of 0.05).
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve \[AUC(0-t) and AUC(0-infinity)\], and apparent terminal phase half-life (t1/2). AUC(0-infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
From the plasma concentration-time data, the following PK parameters will be determined: maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve \[AUC(0-t) and AUC(0-infinity)\], and apparent terminal phase half-life (t1/2). AUC(0- infinity) or AUC(0-τ) and Cmax following single and repeat doses may be used for assessment of dose proportionality.
Safety and tolerability parameters assessments include adverse events, clinical laboratory, ECG, vital signs, and concurrent medication
| Arm | Type | Description |
|---|---|---|
| placebo | PLACEBO_COMPARATOR | placebo |
| 50 mg | ACTIVE_COMPARATOR | 50 mg GSK557296 |
| 150 mg | ACTIVE_COMPARATOR | 150 mg GSK557296 |
| Cohort 1: GSK557296 10 mg | EXPERIMENTAL | GSK557296 10 mg single dose on Day 1 followed by repeat dosing (4 times a day) on Days 2-6 |
| Cohort 2: GSK557296 150 mg | EXPERIMENTAL | GSK557296 150 mg as a single dose on Day 1 followed by repeat nominal dosing of the same dose (either 2, 3 or 4 times a day based on half-life demonstrated in treatment A) on Days 9-13 |
| Cohort 3 | EXPERIMENTAL | This study had an adaptive design and additional cohorts may be added depending on the PK profiles of Cohort 1 and Cohort 2. Subjects in this optional Cohort 3 will receive GSK557296 (dose to be determined) as a single dose on Day 1 followed by repeat nominal dosing of the same dose (either 2, 3 or 4 times a day based on half-life demonstrated in Cohort 1 and Cohort 2) on Days 2-6 |
| Cohort 4 | EXPERIMENTAL | This study had an adaptive design and additional cohorts may be added depending on the PK profiles of Cohort 1 and Cohort 1. Subjects in this optional Cohort 4 will receive GSK557296 (dose to be determined) by PK of prior doses, 10-150 mg single dose on Day 1 followed by repeat dosing (either 2, 3 or 4 times a day dependent on half-life demonstrated in prior groups) on Days 2-6 |
| Name | Type | Description |
|---|---|---|
| GSK557296 | DRUG | 50 mg GSK557296 |
| placebo | DRUG | placebo |
| GSK557296 10 mg | DRUG | 10 mg single oral dose. Each subject will receive 2 tablets of 5 mg GSK557296 four times a day (QID). |
| GSK557296 150 mg | DRUG | 150 mg single oral dose. Each subject will receive multiple tablets of 25 mg GSK557296 either 2, 3 or 4 times a day. |
| GSK557296 dose 3 | DRUG | Dose to be determined as a single dose tablet based on half-life demonstrated in Cohort 1 and Cohort 2. |
| GSK557296 dose 4 | DRUG | Dose to be determined by PK of prior doses, based on half-life demonstrated in prior cohorts. |
Inclusion Criteria: 1. Males with primary PE, according to the ISSM Consensus Definition. Defined as, a male sexual dysfunction characterized by ejaculation which always or nearly always occurs prior to or within about one minute of vaginal penetration; and, inability to delay ejaculation on all or...
GSK557296 is an investigational small molecule being studied for conditions including premature ejaculation, obstetric labour, and embryo transfer. It has been evaluated in clinical trials for these indications, though it remains in development and is not approved.
GSK557296 is being developed by GSK plc, a global biopharma company traded on the London Stock Exchange under the ticker GSK. The company has sponsored clinical trials of the drug in the United States and the Netherlands.
GSK557296 has completed Phase 1 and Phase 2 clinical trials. The most advanced study was a Phase 2 trial in men with premature ejaculation, which has been completed. The drug is investigational and not yet approved.
GSK557296 has been studied in three completed trials: NCT00549211, a Phase 1 first-in-human study in healthy male volunteers; NCT01021553, a Phase 2 study in men with premature ejaculation; and NCT01669083, a Phase 1 study in healthy women volunteers. All trials are completed.
GSK557296 is a small molecule, but its specific molecular target has not been disclosed in the available clinical trial information. The trials focused on its safety, tolerability, pharmacokinetics, and pharmacodynamics in the studied populations.