A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
LIN-PK-01
An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically
1 other identifier
interventional
7
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2014
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 31, 2014
CompletedFirst Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
August 19, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedDecember 19, 2020
December 1, 2020
4.8 years
August 12, 2014
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
From Baseline (Day 1) to Day 4
Study Arms (1)
linaclotide
EXPERIMENTALLinaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Iowa
Iowa City, Iowa, 52242, United States
Digestive Disease Specialists Inc (DDSI)
Oklahoma City, Oklahoma, 73112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ramesh Boinpally, PhD
Forest Research Institute, an affiliate of Allergan plc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2014
First Posted
August 19, 2014
Study Start
July 31, 2014
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
December 19, 2020
Record last verified: 2020-12