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This is a randomized, open-label study to evaluate the effect of a single dose of SSP-004184 on the pharmacokinetics of a single dose of simvastatin in healthy adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug |
| ||
| SSP-004184SS |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin | 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. | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours. |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin | 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. | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours. |
| Maximum Plasma Concentration (Cmax) of Simvastatin | 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. | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc. | Miami | Florida | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Simvastatin First | Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2. |
| FG001 | Simvastatin + SSP-004184SS First | Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
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Safety Set: All subjects who had taken at least 1 dose of investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Simvastatin First | Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2. |
| BG001 | Simvastatin + SSP-004184SS First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) for Simvastatin | 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. | Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | ng*h/ml | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Simvastatin Alone | Administered as a single oral 20 mg dose on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Drug |
|
|
| NOT COMPLETED |
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|
Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Simvastatin + SSP-004184SS | Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1. |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of Simvastatin | 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. | Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | ng*h/ml | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours. |
|
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Simvastatin | 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. | Pharmacokinetic Set: All subjects who took at least 1 dose of investigational product and for whom the primary pharmacokinetic data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | ng/mL | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72 hours. |
|
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Simvastatin + SSP-004184SS | Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1. | 0 | 30 | 2 | 30 |
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.
If the 90% CI of the geometric mean ratios fell within the range (0.80, 1.25), then equivalence was assumed and the hypothesis that a drug interaction occurred was rejected. If the 90% CIs were not wholly contained within the range (0.80, 1.25), then a drug interaction was not excluded.