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OpenTrials
Completed

NCT Number: NCT02649062

Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

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.

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Key information

Conditions

Functional Constipation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

NGM Clinical Study Site 1

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NGM282

Biological

Placebo

Other

Primary outcomes

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

    Time frame: 9 days

Secondary outcomes

  1. Clinical Laboratory Assessments

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

NGM Biopharmaceuticals, Inc

Industry

Registry information

Official study title

Study of the Pharmacodynamics of NGM282 on Colonic Transit, Bile Acid Homeostasis, and Fecal Fat in Subjects With Functional Constipation and Healthy Individuals

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 7, 2016
Registry last updated
Mar 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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