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To assess the effect of food on the pharmacokinetic profile of SSP-004184 compared to administration under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSP-004184SS | Drug | Disodium salt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions | 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. | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours. |
| Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions | 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. | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours. |
| Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions | 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, 4, 8, 12, 24, 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 | Miami | Florida | 33014 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SSP-004184SS Fed First | Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions. |
| FG001 | SSP-004184SS Fasted First | Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
The Safety Set consists of all subjects who have taken at least 1 dose of investigational product and have at least 1 post-dose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | SSP-004184SS Fed First | Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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) of SSP-004184 Under Fasted and Fed Conditions | 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. | Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | ng*hr/mL | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 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 | SSP-004184SS (Fed) | 21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain in extremity | Musculoskeletal and connective tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| NOT COMPLETED |
|
|
| SSP-004184SS Fasted First |
Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| SSP-004184SS (Fasted) |
21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions. |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions | 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. | Pharmacokinetic Set: All subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | ng*hr/mL | Study Periods 1 & 2: Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 2.5, 4, 8, 12, 24, 48, 72 hours. |
|
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions | 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. | 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, 4, 8, 12, 24, 48, 72 hours. |
|
|
|
|
| 0 |
| 9 |
| 5 |
| 9 |
| EG001 | SSP-004184SS (Fasted) | 21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions. | 0 | 9 | 4 | 9 |
| Headache | Nervous system disorders |
|
| Agitation | Psychiatric disorders |
|
| Chromaturia | Renal and urinary disorders |
|
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.