Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SSP-002358 · 1 trial · 1 indication
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
| Arm | Type | Description |
|---|---|---|
| SSP-002358 alone | EXPERIMENTAL | - |
| SSP-002358 + omeprazole | EXPERIMENTAL | SSP-002358 + omeprazole |
| Name | Type | Description |
|---|---|---|
| SSP-002358 | DRUG | 1 mg, oral, once |
| SSP-002358 + omeprazole | DRUG | SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once |
Inclusion criteria: 1. Age 18-55 years inclusive at the time of consent. 2. Subject is willing to comply with any applicable contraceptive requirements of the protocol and is: * Male, or * Non-pregnant, non-lactating female * Females must be at least 90 days post-partum or nulliparous. E...
SSP-002358 is an investigational small molecule being studied for use in healthy volunteers and in patients with Gastroesophageal Reflux Disease (GERD). It is being developed by Takeda Pharmaceutical Company Limited (TAK). The drug is currently in clinical development, with studies completed in both healthy subjects and GERD patients.
SSP-002358 is a selective 5-HT4 receptor agonist, as indicated by the clinical trial title. It is being studied in combination with a proton pump inhibitor (PPI) for the treatment of Gastroesophageal Reflux Disease (GERD). The drug is developed by Takeda Pharmaceutical Company Limited (TAK).
SSP-002358 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational small molecule in clinical development for Gastroesophageal Reflux Disease (GERD) and has been studied in healthy volunteers as well.
SSP-002358 is in clinical development, with completed trials in Phase 1 and Phase 2. The Phase 1 trial studied drug interactions with omeprazole in healthy volunteers, and the Phase 2 trial evaluated the drug in patients with Gastroesophageal Reflux Disease (GERD). It is not approved and remains investigational.
SSP-002358 has two completed clinical trials. NCT01415349 was a Phase 1 drug interaction study with omeprazole in healthy volunteers in the Netherlands. NCT01472939 was a Phase 2 study of the drug combined with a proton pump inhibitor in subjects with Gastroesophageal Reflux Disease (GERD), conducted in the US, Czechia, Germany, Latvia, Poland, and Romania.
SSP-002358 is described as a selective 5-HT4 receptor agonist in the clinical trial title. It is being studied in combination with a proton pump inhibitor for Gastroesophageal Reflux Disease (GERD). The drug is developed by Takeda Pharmaceutical Company Limited (TAK) and is currently investigational.