Back to resultsStudy of NGM282 in Subjects With Functional Constipation and Healthy Individuals
Primary Purpose
Functional Constipation
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NGM282
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Functional Constipation
Eligibility Criteria
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
Sites / Locations
- NGM Clinical Study Site 1
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
NGM282 Dose 1
NGM282 Dose 2
Placebo
Arm Description
NGM282
NGM282
Placebo
Outcomes
Primary Outcome Measures
Effect on Colon Transit, as measured by the movement of food through the colon
Secondary Outcome Measures
Clinical Laboratory Assessments
Full Information
NCT ID
NCT02649062
First Posted
January 4, 2016
Last Updated
March 28, 2018
Sponsor
NGM Biopharmaceuticals, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02649062
Brief Title
Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NGM Biopharmaceuticals, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NGM282 Dose 1
Arm Type
Experimental
Arm Description
NGM282
Arm Title
NGM282 Dose 2
Arm Type
Experimental
Arm Description
NGM282
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Biological
Intervention Name(s)
NGM282
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Effect on Colon Transit, as measured by the movement of food through the colon
Time Frame
9 days
Secondary Outcome Measure Information:
Title
Clinical Laboratory Assessments
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen J Rossi, PharmD
Organizational Affiliation
NGM Biopharmaceuticals, Inc
Official's Role
Study Director
Facility Information:
Facility Name
NGM Clinical Study Site 1
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals
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