- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02220348
A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically (LIN-PK-01)
December 16, 2020 updated by: Forest Laboratories
An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
- Digestive Disease Specialists Inc (DDSI)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: linaclotide
Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
Time Frame: From Baseline (Day 1) to Day 4
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From Baseline (Day 1) to Day 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Ramesh Boinpally, PhD, Forest Research Institute, an affiliate of Allergan plc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2014
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
August 12, 2014
First Submitted That Met QC Criteria
August 18, 2014
First Posted (Estimate)
August 19, 2014
Study Record Updates
Last Update Posted (Actual)
December 19, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Irritable Bowel Syndrome
- Constipation
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Guanylyl Cyclase C Agonists
- Enzyme Activators
- Linaclotide
Other Study ID Numbers
- LIN-PK-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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