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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536209
• Other study ID #: MT-8554-E03
• Status: Completed
• Phase: Phase 1
• First received: August 16, 2015
• Last updated: January 4, 2016
• Start date: August 2015
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• MT-8554 low dose

• MT-8554 high dose

• Oxycodone hydrochloride

• Placebo

Locations

Country	Name	City	State
United Kingdom	Investigational center	City name

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic effect as measured by Visual Analogue Scale for Cold Pressor Test		up to 10 hours post dosing	No
Secondary	Safety and Tolerability as measured by vital signs		up to Day6 of treatment period 4	Yes
Secondary	Safety and Tolerability as measured by ECG		up to Day6 of treatment period 4	Yes
Secondary	Safety and Tolerability as measured by laboratory safety assessments		up to Day6 of treatment period 4	Yes
Secondary	Safety and Tolerability as measured by physical examination		up to Day6 of treatment period 4	Yes
Secondary	Safety and Tolerability as measured by number of participants with adverse events		up to Day6 of treatment period 4	Yes
Secondary	Plasma concentration of MT-8554 at the time of Pharmacodynamic assessments		up to 10 hours post dosing	No
Secondary	Plasma concentration of Oxycodone hydrochloride at the time of Pharmacodynamic assessments		up to 10 hours post dosing	No