NCT02675309

Brief Summary

The purpose of this study is to investigate the effect of MT-8554 on the pharmacokinetics of simvastatin and rosuvastatin in healthy subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Feb 2016

Shorter than P25 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

February 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2016

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

29 days

First QC Date

February 3, 2016

Last Update Submit

December 16, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Area under the plasma concentration-time curve (AUC) of rosuvastatin alone and in the presence of MT-8554.

    72 hours post dose

  • Cmax of rosuvastatin alone and in the presence of MT-8554.

    72 hours post dose

  • AUC of simvastatin/simvastatin acid alone and in the presence of MT-8554.

    24 hours post dose

  • Cmax of simvastatin/simvastatin acid alone and in the presence of MT-8554.

    24 hours post dose

Secondary Outcomes (2)

  • Safety and Tolerability as measured by vital signs

    Up to Day 16

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

    Up to Day 16

Study Arms (1)

MT-8554, rosuvastatin and simvastatin

EXPERIMENTAL

Subjects will be administered a single dose of rosuvastatin followed on Day 4 by a single dose of simvastatin. MT-8554 will be administered from Days 6 to 12 with co-administration of rosuvastatin and simvastatin on Days 9 and 12, respectively.

Drug: MT-8554Drug: rosuvastatinDrug: simvastatin

Interventions

MT-8554DRUG
MT-8554, rosuvastatin and simvastatin
rosuvastatinDRUG
MT-8554, rosuvastatin and simvastatin
simvastatinDRUG
MT-8554, rosuvastatin and simvastatin

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 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

Rosuvastatin CalciumSimvastatin

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsLovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2016

First Posted

February 5, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

GB(1)