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The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen 1 | Experimental | Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing |
|
| Regimen 2 | Experimental | Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing |
|
| Regimen 3 | Experimental | Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing |
|
| Regimen 4 | Experimental | Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-8554 low dose | Drug |
| ||
| MT-8554 high dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test | up to 10 hours post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability as measured by vital signs | up to Day6 of treatment period 4 | |
| Safety and Tolerability as measured by ECG | up to Day6 of treatment period 4 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational center | City Name | United Kingdom |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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| Drug |
|
| Oxycodone hydrochloride | Drug |
|
| Placebo | Drug |
|
| Safety and Tolerability as measured by laboratory safety assessments |
| up to Day6 of treatment period 4 |
| Safety and Tolerability as measured by physical examination | up to Day6 of treatment period 4 |
| Safety and Tolerability as measured by number of participants with adverse events | up to Day6 of treatment period 4 |
| Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments | up to 10 hours post dosing |
| Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments | up to 10 hours post dosing |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |