Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SSP-004184 · 1 trial · 1 indication
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.
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.
| Arm | Type | Description |
|---|---|---|
| SSP-004184 (Mild Renal Impairment) | EXPERIMENTAL | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (Moderate Renal Impairment) | EXPERIMENTAL | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (Severe Renal Impairment) | EXPERIMENTAL | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (End Stage Renal Disease) | EXPERIMENTAL | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (Healthy Elderly Subjects) | EXPERIMENTAL | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1 |
| SSP-004184 (Matched Healthy Subjects) | EXPERIMENTAL | All subjects will take a single dose of SSP-004184 (75 mg/kg, oral capsule) on Day 1. Healthy subjects matched to renally impaired subjects in arms 1 through 4. (Note: One healthy subject can match more than one renally impaired subject.) |
| Name | Type | Description |
|---|---|---|
| SSP-004184 | DRUG | - |
Inclusion Criteria: Healthy subjects * Age 18-85 years inclusive at the time of consent. The elderly treatment group will be defined by an age over 65 years. It is required that at least 4 of the subjects in the elderly group will be over 75 years old. * All subjects will be "healthy" * Normal ren...
SSP-004184 is an investigational small molecule developed by Takeda Pharmaceutical Company Limited for impaired renal function. It has been studied in a Phase 1 clinical trial in healthy adults, elderly subjects, and subjects with impaired renal function. It is not approved and remains in clinical development.
SSP-004184 is being studied for impaired renal function, a nephrology condition. The research has focused on how the drug behaves in healthy adults, elderly subjects, and people with reduced kidney function. It is investigational and has not been approved for any use.
SSP-004184 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program studying the drug in impaired renal function.
SSP-004184 is in Phase 1 clinical development. Its single Phase 1 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for impaired renal function or any other indication.
SSP-004184 has been evaluated in one Phase 1 trial, NCT01716455, titled Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function. The trial enrolled 66 participants in the United States and has been completed.
Yes, SSP-004184 is also known as FBS0701. The alternative name appears in the title of its Phase 1 trial, NCT01716455, which studied the drug in healthy adults, elderly subjects, and subjects with impaired renal function. Both names refer to the same investigational small molecule developed by Takeda.