A Multiple-Ascending Dose Study of MS-553 in Healthy Volu... | NCT02406989

Studies
A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

NCT02406989

Sponsor

MingSight Pharmaceuticals Pty Limited

Status

Completed

Last Update Posted

Mar 16, 2016Estimated

Enrollment

32Actual

Phase

Phase 1

Conditions

Safety and PK in Healthy Volunteers

Interventions

MS-553
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Mar 25, 2015

First Submission Date that Met QC Criteria

Mar 30, 2015

First Posted Date

Apr 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2016

Last Update Posted Date

Mar 16, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
MS-553	Drug	Study Drug	MS-553
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability		14 days

Secondary Outcomes

Measure	Description	Time Frame
Peak Plasma Concentration (Cmax)		14 days
Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve		14 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Network		Melbourne	Victoria	3122	Australia