Safety and Efficacy of Solithromycin in the Treatment of... | NCT02510599

Studies
Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

NCT02510599

Sponsor

Melinta Therapeutics, Inc.

Status

Completed

Last Update Posted

Mar 21, 2017Actual

Enrollment

10Actual

Phase

Phase 2

Conditions

Nonalcoholic Steatohepatitis

Interventions

solithromycin

Countries

United States

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 2017

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

Dec 2015Actual

Primary Completion Date

Jan 27, 2017Actual

Completion Date

Feb 28, 2017Actual

First Submitted Date

Jul 1, 2015

First Submission Date that Met QC Criteria

Jul 28, 2015

First Posted Date

Jul 29, 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

Mar 17, 2017

Certification/Extension First Submitted that Passed QC Review

Mar 17, 2017

Certification/Extension First Posted Date

Mar 20, 2017Actual

Last Update Submitted Date

Mar 20, 2017

Last Update Posted Date

Mar 21, 2017Actual

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

The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.

Detailed Description

Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Solithromycin	Experimental	Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks	Drug: solithromycin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
solithromycin	Drug		Solithromycin	CEM-101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate effects on hepatic histology in patients with NASH	Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)	13 weeks

Secondary Outcomes

Measure	Description	Time Frame
Changes in Steatosis on liver biopsy	Graded from 0 to 3	13 weeks
Changes in hepatocellular ballooning score on liver biopsy	Graded from 0 to 2

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologic evidence of NASH based on liver biopsy obtained within 180 days
NAS> or = 5
Able to swallow capsules intact

Exclusion Criteria:

Symptoms of acute liver disease
Cirrhosis on liver biopsy
Positive HIV or Hepatitis tests
Primary Biliary Cirrhosis
Poorly controlled diabetes with HgA1C >8.5%
ALT >4-fold upper limit of normal
QTcF >450 msec
CrCl <40 mL/min

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Dobbins, MD, PhD	Melinta Therapeutics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Case Western University Hospitals		Cleveland	Ohio	44106	United States

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D008107	Liver Diseases

Ancestor Terms

ID	Term
D005234	Fatty Liver
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C547755	solithromycin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided