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NCT02649062 Clinical Trial

Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

Functional Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02649062
Other study ID # 15-0107
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 4, 2016
Last updated March 28, 2018
Start date December 2015
Est. completion date January 2017

Study information
Verified date March 2018
Source NGM Biopharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• NGM282

Other:
• Placebo

Locations
Country Name City State
United States NGM Clinical Study Site 1 Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
NGM Biopharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect on Colon Transit, as measured by the movement of food through the colon 9 days
Secondary Clinical Laboratory Assessments 14 days
See also
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