A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02536209
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Regimen 1 MT-8554 low dose Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing Regimen 1 MT-8554 high dose Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing Regimen 3 MT-8554 high dose Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing Regimen 1 Oxycodone hydrochloride 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 MT-8554 low dose Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing Regimen 4 MT-8554 low dose Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing Regimen 4 MT-8554 high dose Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing Regimen 1 Placebo 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 MT-8554 high dose 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 Placebo Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing Regimen 2 Oxycodone hydrochloride Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing Regimen 2 Placebo 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 MT-8554 low dose 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 Placebo Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing Regimen 3 Oxycodone hydrochloride 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 Oxycodone hydrochloride Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing
- Primary Outcome Measures
Name Time Method Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test up to 10 hours post dosing
- Secondary Outcome Measures
Name Time Method Safety and Tolerability as measured by physical examination 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 vital signs up to Day6 of treatment period 4 Safety and Tolerability as measured by laboratory safety assessments up to Day6 of treatment period 4 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 Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments up to 10 hours post dosing
Trial Locations
- Locations (1)
Investigational center
🇬🇧City name, United Kingdom