Study of NGM282 in Subjects With Functional Constipation... | NCT02649062

Studies
Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals

NCT02649062

Sponsor

NGM Biopharmaceuticals, Inc

Status

Completed

Last Update Posted

Mar 30, 2018Actual

Enrollment

31Actual

Phase

Phase 1Phase 2

Conditions

Functional Constipation

Interventions

NGM282
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Jan 4, 2016

First Submission Date that Met QC Criteria

Jan 5, 2016

First Posted Date

Jan 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Mar 28, 2018

Certification/Extension First Submitted that Passed QC Review

Mar 28, 2018

Certification/Extension First Posted Date

Mar 30, 2018Actual

Last Update Submitted Date

Mar 28, 2018

Last Update Posted Date

Mar 30, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NGM282 Dose 1	Experimental	NGM282	Biological: NGM282
NGM282 Dose 2	Experimental	NGM282	Biological: NGM282
Placebo	Placebo Comparator	Placebo	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NGM282	Biological		NGM282 Dose 1 NGM282 Dose 2
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effect on Colon Transit, as measured by the movement of food through the colon		9 days

Secondary Outcomes

Measure	Description	Time Frame
Clinical Laboratory Assessments		14 days

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephen J Rossi, PharmD	NGM Biopharmaceuticals, Inc	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NGM Clinical Study Site 1		Rochester	Minnesota	55905	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000710649	aldafermin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided