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Study to Assess the Relative Potency of Multiple Oral Doses of LUM001 and SHP626 in Overweight and Obese Adults as Assessed by Fecal Bile Acid Excretion

NCT02475317 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2019-04-04

No results posted yet for this study

Summary

The purpose of this study is to assess the relative potency of multiple oral doses of LUM001 and SHP626 administered for 7 days as assessed by fecal bile acid excretion in overweight and obese adult subjects. This study is designed to address the relative potency question for the first time in the same.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Placebo

Participants will receive placebo matched to maralixibat/volixibat orally for 7 days.

DRUG

Maralixibat

Participants will receive maralixibat in 10 mg, 20 mg, 50 mg or 100 mg doses.

DRUG

Volixibat

Participants will receive volixibat in 10 mg and 20 mg doses.

Sponsors & Collaborators

  • Mirum Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Mirum

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2015-12-01
Completion
2015-12-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02475317 on ClinicalTrials.gov