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

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ClinicalTrials.gov Identifier: NCT02536209
Recruitment Status : Completed
First Posted : August 31, 2015
Last Update Posted : January 6, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: MT-8554 low dose Drug: MT-8554 high dose Drug: Oxycodone hydrochloride Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Study Start Date : August 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Regimen 1
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
Drug: MT-8554 high dose
Drug: Oxycodone hydrochloride
Drug: Placebo
Experimental: Regimen 2
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
Drug: MT-8554 high dose
Drug: Oxycodone hydrochloride
Drug: Placebo
Experimental: Regimen 3
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
Drug: MT-8554 high dose
Drug: Oxycodone hydrochloride
Drug: Placebo
Experimental: Regimen 4
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
Drug: MT-8554 high dose
Drug: Oxycodone hydrochloride
Drug: Placebo



Primary Outcome Measures :
  1. Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test [ Time Frame: up to 10 hours post dosing ]

Secondary Outcome Measures :
  1. Safety and Tolerability as measured by vital signs [ Time Frame: up to Day6 of treatment period 4 ]
  2. Safety and Tolerability as measured by ECG [ Time Frame: up to Day6 of treatment period 4 ]
  3. Safety and Tolerability as measured by laboratory safety assessments [ Time Frame: up to Day6 of treatment period 4 ]
  4. Safety and Tolerability as measured by physical examination [ Time Frame: up to Day6 of treatment period 4 ]
  5. Safety and Tolerability as measured by number of participants with adverse events [ Time Frame: up to Day6 of treatment period 4 ]
  6. Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments [ Time Frame: up to 10 hours post dosing ]
  7. Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments [ Time Frame: up to 10 hours post dosing ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536209


Locations
United Kingdom
Investigational center
City name, United Kingdom
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02536209     History of Changes
Other Study ID Numbers: MT-8554-E03
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: January 6, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents