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CompletedNCT02429102Updated Dec 22, 2025

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-8554 in Healthy Subjects

A Phase 1 interventional study of MT-8554 and Placebo in Healthy, sponsored by Tanabe Pharma Corporation. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by Tanabe Pharma Corporation · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
135
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy

Keywords

  • Phase 1
  • Healthy subjects
  • Pharmacokinetics of MT-8554
03

In context

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
135 participants (actual)

Study arms

  • Experimental
    Single ascending dose, MT-8554 or Placebo

    Drug: MT-8554 · Drug: Placebo

  • Experimental
    Multiple ascending dose, MT-8554 or Placebo

    Drug: MT-8554 · Drug: Placebo

Interventions

  • DrugMT-8554
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Safety and Tolerability as measured by vital signs

    Time frame: up to Day14

  2. Safety and Tolerability as measured by ECG

    Time frame: up to Day14

  3. Safety and Tolerability as measured by continuous lead II ECG monitoring

    Time frame: up to Day14

  4. Safety and Tolerability as measured by laboratory safety assessments

    Time frame: up to Day14

  5. Safety and Tolerability as measured by physical examination

    Time frame: up to Day14

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

    Time frame: up to Day14

Secondary outcomes

  1. PK profile (Cmax, tmax, t½, AUC)

    Cmax, tmax, t½, AUC

    Time frame: 240 hours post dose

07

Study locations

1 site
  • Investigational center
    City Name, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02429102
Lead sponsor
Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Apr 29, 2015
Start date
Apr 2015
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Dec 22, 2025

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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