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

• Status: Completed
• Trial end date: 2017-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cempra Inc; Melinta Therapeutics, Inc.
• Treatments: Solithromycin

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