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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Oxycodone hydrochloride; Drug: MT-8554 low dose; Drug: MT-8554 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT02536209

MT-8554-E03

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups

Regimen 1

Experimental group

Description:

Period 1: MT-8554 low dose, Period 2: MT-8554 high dose, Period 3: Placebo and Period 4: Oxycodone hydrochloride, respectively single dosing

Treatment:

Drug: MT-8554 high dose

Drug: MT-8554 low dose

Drug: Placebo

Drug: Oxycodone hydrochloride

Regimen 2

Experimental group

Description:

Period 1: MT-8554 high dose, Period 2: Oxycodone hydrochloride, Period 3: MT-8554 low dose and Period 4: Placebo, respectively single dosing

Treatment:

Drug: MT-8554 high dose

Drug: MT-8554 low dose

Drug: Placebo

Drug: Oxycodone hydrochloride

Regimen 3

Experimental group

Description:

Period 1: Placebo, Period 2: MT-8554 low dose, Period 3: Oxycodone hydrochloride and Period 4: MT-8554 high dose, respectively single dosing

Treatment:

Drug: MT-8554 high dose

Drug: MT-8554 low dose

Drug: Placebo

Drug: Oxycodone hydrochloride

Regimen 4

Experimental group

Description:

Period 1: Oxycodone hydrochloride, Period 2: Placebo, Period 3: MT-8554 high dose and Period 4: MT-8554 low dose, respectively single dosing

Treatment:

Drug: MT-8554 high dose

Drug: MT-8554 low dose

Drug: Placebo

Drug: Oxycodone hydrochloride