Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

NGM Biopharmaceuticals, Inc31 enrolled

Overview

The purpose of this study is to determine the effect of NGM282 on colonic transit, bile acid homeostasis, and fecal fat in subjects with functional constipation and healthy individuals.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Functional Constipation

Interventions

NGM282BIOLOGICAL

PlaceboOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Functional constipation confirmed by modified Rome III criteria or Healthy Volunteer Exclusion Criteria: * Structural or metabolic diseases/conditions that affect the GI system * Diagnosis of dyspepsia, IBS, or significant gastrointestinal symptoms

Locations (1)

NGM Clinical Study Site 1

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Effect on Colon Transit, as measured by the movement of food through the colon

Time frame: 9 days

Secondary Outcomes

Clinical Laboratory Assessments

Time frame: 14 days

Data from ClinicalTrials.gov

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