NCT02510599

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_2

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

July 1, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 29, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

July 1, 2015

Last Update Submit

March 20, 2017

Conditions

Nonalcoholic Steatohepatitis

Keywords

NASHLiver disease

Outcome Measures

Primary Outcomes (1)

  • To evaluate effects on hepatic histology in patients with NASH

    Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)

    13 weeks

Secondary Outcomes (3)

  • Changes in Steatosis on liver biopsy

    13 weeks

  • Changes in hepatocellular ballooning score on liver biopsy

    13 weeks

  • Changes in inflammation on liver biopsy

    13 weeks

Study Arms (1)

Solithromycin

EXPERIMENTAL

Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks

Drug: solithromycin

Interventions

solithromycinDRUG
Also known as: CEM-101
Solithromycin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Western University Hospitals

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseLiver Diseases

Interventions

solithromycin

Condition Hierarchy (Ancestors)

Fatty LiverDigestive System Diseases

Study Officials

  • Robert Dobbins, MD, PhD

    Melinta Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 29, 2015

Study Start

December 1, 2015

Primary Completion

January 27, 2017

Study Completion

February 28, 2017

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations

US(1)