Back to resultsA Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically (LIN-PK-01)
Primary Purpose
Breast Feeding, Constipation, Irritable Bowel Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
linaclotide
Sponsored by
About this trial
This is an interventional other trial for Breast Feeding focused on measuring Linzess
Eligibility Criteria
Inclusion Criteria:
- Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks
- Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
- Weaning must not be underway
- Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection
Exclusion Criteria:
- Clinically significant disease state in any body system, except for the indication being treated with linaclotide
- Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility
- Participation in any other clinical investigation using an experimental drug within 90 days
Sites / Locations
- University of Iowa
- Digestive Disease Specialists Inc (DDSI)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
linaclotide
Arm Description
Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration
Outcomes
Primary Outcome Measures
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02220348
Brief Title
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
Acronym
LIN-PK-01
Official Title
An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 31, 2014 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Feeding, Constipation, Irritable Bowel Syndrome
Keywords
Linzess
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
linaclotide
Arm Type
Experimental
Arm Description
Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration
Intervention Type
Drug
Intervention Name(s)
linaclotide
Other Intervention Name(s)
Linzess
Primary Outcome Measure Information:
Title
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
Time Frame
From Baseline (Day 1) to Day 4
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks
Be already taking linaclotide therapeutically for Irritable Bowel Syndrome with Constipation (IBS-C) or Chronic Idiopathic Constipation (CIC)
Weaning must not be underway
Be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection
Exclusion Criteria:
Clinically significant disease state in any body system, except for the indication being treated with linaclotide
Any structural abnormality of the gastrointestinal (GI) tract, or a disease or condition that can affect GI motility
Participation in any other clinical investigation using an experimental drug within 90 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramesh Boinpally, PhD
Organizational Affiliation
Forest Research Institute, an affiliate of Allergan plc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Digestive Disease Specialists Inc (DDSI)
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
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