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A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis

NCT03394924 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2021-05-18

Study results available
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Summary

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with primary biliary cholangitis

Conditions

Interventions

DRUG

EDP-305 1 mg

Two tablets daily for 12 weeks

DRUG

EDP-305 2.5 mg

Two tablets daily for 12 weeks

DRUG

Placebo

Two tablets daily for 12 weeks

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Triangle Biostatistics, LLC

    collaborator INDUSTRY

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-27
Primary Completion
2019-12-19
Completion
2020-01-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03394924 on ClinicalTrials.gov