NCT02429102

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-8554 in healthy Caucasian subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2015

Typical duration for phase_1 healthy

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

April 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
6 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

7 months

First QC Date

April 16, 2015

Last Update Submit

December 16, 2025

Conditions

Healthy

Keywords

Phase 1Healthy subjectsPharmacokinetics of MT-8554

Outcome Measures

Primary Outcomes (6)

  • Safety and Tolerability as measured by vital signs

    up to Day14

  • Safety and Tolerability as measured by ECG

    up to Day14

  • Safety and Tolerability as measured by continuous lead II ECG monitoring

    up to Day14

  • Safety and Tolerability as measured by laboratory safety assessments

    up to Day14

  • Safety and Tolerability as measured by physical examination

    up to Day14

  • Safety and Tolerability as measured by number of participants with adverse events

    up to Day14

Secondary Outcomes (1)

  • PK profile (Cmax, tmax, t½, AUC)

    240 hours post dose

Study Arms (2)

Single ascending dose, MT-8554 or Placebo

EXPERIMENTAL
Drug: MT-8554Drug: Placebo

Multiple ascending dose, MT-8554 or Placebo

EXPERIMENTAL
Drug: MT-8554Drug: Placebo

Interventions

MT-8554DRUG
Multiple ascending dose, MT-8554 or PlaceboSingle ascending dose, MT-8554 or Placebo
PlaceboDRUG
Multiple ascending dose, MT-8554 or PlaceboSingle ascending dose, MT-8554 or Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy and free from clinically significant illness or disease
  • Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
  • A body weight of ≥60 kg male and ≥50 kg female

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

Study Design

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

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 29, 2015

Study Start

April 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)