Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SPD602
SSP-004184SS · 4 trials · 3 indications
LIC was determined by R2 Magnetic Resonance Imaging (MRI).
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 |
|---|---|---|
| SPD602 (16mg) | EXPERIMENTAL | - |
| SPD602 (32mg) | EXPERIMENTAL | - |
| 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 |
|---|---|---|
| SPD602 (FBS0701, SSP-004184) | DRUG | Oral FBS0701 taken one time daily for up to 96 weeks. |
| Midazolam | DRUG | - |
| SSP-004184SS | DRUG | - |
| Simvastatin | DRUG | - |
Inclusion Criteria: * Transfusional iron overload due to: hereditary anemias such as sickle cell disease, β-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure. Patients must also be transfusion-dependent and require chro...
SSP-004184SS is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It has been studied in Phase 1 clinical trials in healthy adult volunteers, with three completed trials enrolling a total of 69 participants. No therapeutic indication for SSP-004184SS has been disclosed.
SSP-004184SS is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored all three of the Phase 1 trials of SSP-004184SS conducted in the United States.
SSP-004184SS is in Phase 1 clinical development. All three of its registered trials are Phase 1 studies, and all three are completed. There are no active trials of SSP-004184SS at this time. It is an investigational drug and has not been approved by the FDA.
SSP-004184SS has been studied in three completed Phase 1 trials: NCT01989169, which examined a pharmacokinetic interaction with midazolam in 30 healthy adults; NCT01979185, which examined the effect of SSP-004184SS on simvastatin pharmacokinetics in 30 healthy adults; and NCT01905553, which assessed the effect of food on bioavailability in 9 healthy adults.
The SSP-004184SS Phase 1 trials were controlled and randomized, but not double blind. All three enrolled healthy adult volunteers aged 18 years and older in the United States, with a combined enrollment of 69 participants. None of the trials used biomarker-based patient selection.