Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SSP-004184SS · 3 trials · 1 indication
AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. 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.
AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. 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.
AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. 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.
AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. 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.
AUCinf is the 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.
AUClast is the area under the curve from the time of dosing to the last measurable concentration. 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 |
|---|---|---|
| Midazolam | ACTIVE_COMPARATOR | Administered as a single oral 6 mg dose on Day 1. |
| SSP-004184SS + Midazolam | EXPERIMENTAL | Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1. |
| Simvastatin | ACTIVE_COMPARATOR | Administered as a single oral 20 mg dose on Day 1. |
| Simvastatin + SSP-004184SS | EXPERIMENTAL | Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1. |
| SSP-004184SS (fed) | EXPERIMENTAL | 21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions |
| SSP-004184SS (fasted) | EXPERIMENTAL | 21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions |
| Name | Type | Description |
|---|---|---|
| Midazolam | DRUG | - |
| SSP-004184SS | DRUG | - |
| Simvastatin | DRUG | - |
Inclusion Criteria: * Normal healthy male and female volunteers between the ages of 18 and 65, inclusive * Serum ferritin, hemoglobin and erythrocyte indices within normal range Exclusion Criteria: * Evidence of any active or chronic disease
SSP-004184SS is an investigational small molecule being studied in healthy adult subjects. It is currently in Phase 1 clinical development, with completed trials evaluating its bioavailability, drug interactions, and pharmacokinetics. It is not approved for any medical condition and remains under investigation.
SSP-004184SS is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting Phase 1 clinical trials to evaluate the drug's properties in healthy volunteers.
SSP-004184SS is in Phase 1 clinical development. All three of its clinical trials have been completed, with a total enrollment of 69 healthy adult subjects. The drug is investigational and has not been approved by regulatory authorities.
SSP-004184SS has been studied in three completed Phase 1 trials: NCT01905553, which examined the effect of food on its bioavailability; NCT01979185, which assessed its effect on simvastatin pharmacokinetics; and NCT01989169, which evaluated its interaction with midazolam. All trials enrolled healthy adults in the United States.
Yes, SSP-004184SS is also known as SPD602. Clinical trial titles for NCT01979185 and NCT01989169 refer to the drug as SSP-004184 (SPD602), confirming that these names refer to the same investigational compound.