Healthy
Conditions
Brief summary
The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.
Interventions
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test | up to 10 hours post dosing |
Secondary
| Measure | Time frame |
|---|---|
| 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 vital signs | 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 |
| Safety and Tolerability as measured by number of participants with adverse events | up to Day6 of treatment period 4 |
Countries
United Kingdom
Outcome results
None listed