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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01989169 | Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects | PHASE1 | COMPLETED | 30 | — | — | Nov 26, 2013 | Jan 6, 2014 | Jun 24, 2021 | 1 | United States |
| NCT01979185 | Effect of SSP-004184 (SPD602) on the Pharmacokinetics of Simvastatin in Healthy Adult Subjects | PHASE1 | COMPLETED | 30 | — | — | Nov 18, 2013 | Dec 13, 2013 | Jun 24, 2021 | 1 | United States |
| NCT01905553 | The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects | PHASE1 | COMPLETED | 9 | — | — | Aug 27, 2013 | Sep 24, 2013 | Jun 24, 2021 | 1 | United States |
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