A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.

Conditions
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Healthy

Intervention / Treatment
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* Drug: MT-8554 low dose
* Drug: MT-8554 high dose
* Drug: Oxycodone hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy and free from clinically significant illness or disease Male Caucasian subjects aged 18 to 55 A body weight of ≥60 kg Exclusion Criteria: Participation in more than three clinical studies involving administration of an Investigational Medicinal Product (IMP) in the previous year, or any study within 12 weeks. Clinically significant endocrine, thyroid, hepatic, respiratory, gastro-intestinal, renal, cardiovascular disease, or history of any significant psychiatric/psychotic illness disorder. Clinically relevant abnormal medical history, physical findings or laboratory values

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regimen 1<br>Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing | Drug: MT-8554 low dose<br> <br> Drug: MT-8554 high dose<br> <br> Drug: Oxycodone hydrochloride<br> <br> Drug: Placebo<br> <br> |
| Experimental: Regimen 2<br>Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing | Drug: MT-8554 low dose<br> <br> Drug: MT-8554 high dose<br> <br> Drug: Oxycodone hydrochloride<br> <br> Drug: Placebo<br> <br> |
| Experimental: Regimen 3<br>Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing | Drug: MT-8554 low dose<br> <br> Drug: MT-8554 high dose<br> <br> Drug: Oxycodone hydrochloride<br> <br> Drug: Placebo<br> <br> |
| Experimental: Regimen 4<br>Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing | Drug: MT-8554 low dose<br> <br> Drug: MT-8554 high dose<br> <br> Drug: Oxycodone hydrochloride<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test |  | up to 10 hours post dosing | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |