NCT02536209

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

August 16, 2015

Last Update Submit

December 16, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test

    up to 10 hours post dosing

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (4)

Regimen 1

EXPERIMENTAL

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 doseDrug: MT-8554 high doseDrug: Oxycodone hydrochlorideDrug: Placebo

Regimen 2

EXPERIMENTAL

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 doseDrug: MT-8554 high doseDrug: Oxycodone hydrochlorideDrug: Placebo

Regimen 3

EXPERIMENTAL

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 doseDrug: MT-8554 high doseDrug: Oxycodone hydrochlorideDrug: Placebo

Regimen 4

EXPERIMENTAL

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 doseDrug: MT-8554 high doseDrug: Oxycodone hydrochlorideDrug: Placebo

Interventions

MT-8554 low doseDRUG
Regimen 1Regimen 2Regimen 3Regimen 4
MT-8554 high doseDRUG
Regimen 1Regimen 2Regimen 3Regimen 4
Oxycodone hydrochlorideDRUG
Regimen 1Regimen 2Regimen 3Regimen 4
PlaceboDRUG
Regimen 1Regimen 2Regimen 3Regimen 4

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy and free from clinically significant illness or disease
  • Male Caucasian subjects aged 18 to 55
  • A body weight of ≥60 kg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigational center

City Name, United Kingdom

Location

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2015

First Posted

August 31, 2015

Study Start

August 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

GB(1)