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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

August 16, 2015
August 31, 2015
January 6, 2016
August 2015
November 2015   (Final data collection date for primary outcome measure)
Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test [ Time Frame: up to 10 hours post dosing ]
Same as current
Complete list of historical versions of study NCT02536209 on ClinicalTrials.gov Archive Site
  • Safety and Tolerability as measured by vital signs [ Time Frame: up to Day6 of treatment period 4 ]
  • Safety and Tolerability as measured by ECG [ Time Frame: up to Day6 of treatment period 4 ]
  • Safety and Tolerability as measured by laboratory safety assessments [ Time Frame: up to Day6 of treatment period 4 ]
  • Safety and Tolerability as measured by physical examination [ Time Frame: up to Day6 of treatment period 4 ]
  • Safety and Tolerability as measured by number of participants with adverse events [ Time Frame: up to Day6 of treatment period 4 ]
  • Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments [ Time Frame: up to 10 hours post dosing ]
  • Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments [ Time Frame: up to 10 hours post dosing ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate the Pharmacodynamic Effect of Single Doses of MT-8554 in Healthy Subjects
Not Provided
The purpose of this study is to investigate the pharmacodynamic effect of single doses of MT-8554 in healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Healthy
  • Drug: MT-8554 low dose
  • Drug: MT-8554 high dose
  • Drug: Oxycodone hydrochloride
  • Drug: Placebo
  • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • 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
    Interventions:
    • Drug: MT-8554 low dose
    • Drug: MT-8554 high dose
    • Drug: Oxycodone hydrochloride
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Same as current
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT02536209
MT-8554-E03
No
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP