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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001565-41 | EudraCT Number |
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This is a drug interaction study evaluating whether blood plasma concentrations of SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSP-002358 alone | Experimental |
| |
| SSP-002358 + omeprazole | Experimental | SSP-002358 + omeprazole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSP-002358 | Drug | 1 mg, oral, once |
| |
| SSP-002358 + omeprazole |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) for SSP-002358 | 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. | Assessed over 48 hours post-dose |
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 | 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. | Assessed over 48 hours post-dose |
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Inclusion criteria:
Age 18-55 years inclusive at the time of consent.
Subject is willing to comply with any applicable contraceptive requirements of the protocol and is:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA International | Zuidlaren | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | SSP-002358 First | A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2 |
| FG001 | SSP-002358 + Omeprazole First | A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| |||||||||||||||||||||
| Treatment Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Safety Analysis Set | Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. |
| 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 | Maximum Plasma Concentration (Cmax) for SSP-002358 | 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 Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis. | Posted | Mean | Standard Deviation | ng/ml | Assessed over 48 hours post-dose |
|
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Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
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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-002358 Alone | All subjects that received only SSP-002358 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distention | Gastrointestinal 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 |
|---|---|
| C000600233 | revexepride |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once |
|
| NOT COMPLETED |
|
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
All subjects that received SSP-002358 + Omeprazole |
|
|
|
| Primary | Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358 | 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 Analysis Set defined as all subjects in the Safety Analysis Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Subjects who vomited or experienced significant diarrhea between dosing and 10 hours post-dose were excluded from the pharmacokinetic descriptive statistics and statistical analysis. | Posted | Mean | Standard Deviation | ng*h/ml | Assessed over 48 hours post-dose |
|
|
|
|
| 0 |
| 40 |
| 37 |
| 40 |
| EG001 | SSP-002358 + Omeprazole | All subjects that received SSP-002358 + Omeprazole | 0 | 42 | 38 | 42 |
| Abdominal pain | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
|
| Flatulence | Gastrointestinal disorders |
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| Gastrointestinal sounds abnormal | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Catheter site related reaction | General disorders |
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| Dizziness | Nervous system disorders |
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| Headache | Nervous system disorders |
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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.
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |