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To obtain absorption, metabolism and excretion data for parent drug and any metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-OPS-2071 | Experimental | Suspension containing 50 mg of 14C-OPS-2071 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-OPS-2071 | Drug | Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly. |
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| Measure | Description | Time Frame |
|---|---|---|
| The Amounts of Radioactivity Excreted in Urine and Faeces | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose. | up to144-168h postdose. |
| Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites. | predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose. |
| AUC of OPS-2071 in Plasma | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma. | predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoshitaka Kotobuki | Small Global, Division of New Product Evaluation and Development | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | 14C-OPS-2071 | Suspension containing 50 mg of 14C-OPS-2071 14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 14C-OPS-2071 | Suspension containing 50 mg of 14C-OPS-2071 14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly. |
| 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 | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | The Amounts of Radioactivity Excreted in Urine and Faeces | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose. | Posted | Mean | Standard Deviation | percentage of administered dose | up to144-168h postdose. |
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| Primary | Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites. | Posted | Mean | Standard Deviation | μg eq.·h/L | predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose. |
|
| |||||||||||||||||||||||||||||||||
| Primary | AUC of OPS-2071 in Plasma | A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma. | Posted | Mean | Standard Deviation | μg·h/L | predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose. |
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From informed Consent up to 22 days post dose
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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 | 14C-OPS-2071 | Suspension containing 50 mg of 14C-OPS-2071 14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly. | 0 | 8 | 4 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Ver18.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Ver18.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Ver18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Ver18.0 | Systematic Assessment |
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| Alanine aminotransferase increase | Investigations | MedDRA Ver18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Ver18.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA Ver18.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director, Yoshitaka Kotobuki, Mr | Otsuka Pharmaceutical Co., Ltd. | +81-3-6361-7366 |
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