NCT02406989

Brief Summary

This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics. Subjects are dosed for 14 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

March 25, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

March 25, 2015

Last Update Submit

March 14, 2016

Conditions

Safety and PK in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

    14 days

Secondary Outcomes (2)

  • Peak Plasma Concentration (Cmax)

    14 days

  • Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve

    14 days

Study Arms (2)

MS-553

EXPERIMENTAL

MS-553 oral tablet BID x 14 days

Drug: MS-553

Placebo

PLACEBO COMPARATOR

Placebo oral tablet BID x 14 days

Drug: Placebo

Interventions

MS-553DRUG

Study Drug

MS-553
PlaceboDRUG

Matching placebo to MS-553

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In good general health with BMI 18 to 32 kg/m2. Females must be nonpregnant, nonlactating, postmenopausal at least 2 years or surgically sterilized at least 6 months prior

You may not qualify if:

  • History of skin rash, migraine, or clinically significant ocular diseases, conditions predisposing to QT prolongation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3122, Australia

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

August 1, 2015

Study Completion

September 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

AU(1)