Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SSP-004184 · 2 trials · 3 indications
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.
Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached.
The time it takes for the blood plasma concentration of a substance to halve.
The rate at which a drug is removed from the body.
The distribution of a medication between plasma and the rest of the body.
| Arm | Type | Description |
|---|---|---|
| SSP-004184 (Child-Pugh A Liver Impaired) | EXPERIMENTAL | The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis. |
| SSP-004184 (Child-Pugh B Liver Impaired) | EXPERIMENTAL | - |
| SSP-004184 (Child-Pugh C Liver Impaired) | EXPERIMENTAL | - |
| SSP-004184 (Matched Healthy Subjects) | EXPERIMENTAL | - |
| 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 |
| Name | Type | Description |
|---|---|---|
| SSP-004184 | DRUG | All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 |
Inclusion Criteria: * Age 18-65 years inclusive at the time of consent. * Willingness 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. Subjects who do not ...
SSP-004184 is an investigational small molecule being studied in Phase 1 clinical trials for hepatic impairment and impaired renal function. It is being developed by Takeda Pharmaceutical Company Limited (TAK) in the gastrointestinal therapeutic area. The drug is not approved and remains in clinical development.
SSP-004184 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational small molecule in Phase 1 clinical development for hepatic impairment and impaired renal function.
SSP-004184 is in Phase 1 clinical development. It is an investigational small molecule being studied for hepatic impairment and impaired renal function. The drug is not FDA approved and remains in clinical trials.
SSP-004184 has been studied in two completed Phase 1 clinical trials. NCT01716455 enrolled 66 subjects with impaired renal function, and NCT01732263 enrolled 44 subjects with hepatic impairment. Both trials were conducted in the United States and included healthy volunteers.
SSP-004184 is also known as FBS0701 and SPD602. Clinical trial NCT01716455 refers to the drug as FBS0701, while NCT01732263 refers to it as SPD602. These names refer to the same investigational drug being developed by Takeda.