Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01716455 | Study of SSP-004184 (FBS0701) in Healthy Adults and Elderly Subjects and in Subjects With Impaired Renal Function | PHASE1 | COMPLETED | 66 | — | — | Oct 29, 2012 | Mar 10, 2013 | Jun 10, 2021 | 2 | United States |
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...