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Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)

NCT02609048 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2025-02-25

Study results available
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Summary

The primary objective of this study is to evaluate the effect of seladelpar (MBX-8025) on alkaline phosphatase (AP) levels in participants with primary biliary cirrhosis (PBC).

Conditions

  • Primary Biliary Cirrhosis (PBC)

Interventions

DRUG

Placebo Comparator

Placebo Capsule

DRUG

Experimental: Seladelpar 50 mg

Seladelpar 50 mg capsule

DRUG

Experimental: Seladelpar / MBX-8025 200 mg

Seladelpar 100 mg capsules

Sponsors & Collaborators

Principal Investigators

  • Pol F Boudes, M.D. · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-11-04
Primary Completion
2016-07-01
Completion
2016-07-01

Countries

  • United States
  • Canada
  • Germany
  • Poland
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT02609048 on ClinicalTrials.gov