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A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically (LIN-PK-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02220348
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : December 19, 2020
Information provided by (Responsible Party):
Forest Laboratories

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.

Condition or disease Intervention/treatment Phase
Breast Feeding Constipation Irritable Bowel Syndrome Drug: linaclotide Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically
Actual Study Start Date : July 31, 2014
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: linaclotide
Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration
Drug: linaclotide
Other Name: Linzess

Primary Outcome Measures :
  1. Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk [ Time Frame: From Baseline (Day 1) to Day 4 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02220348

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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Oklahoma
Digestive Disease Specialists Inc (DDSI)
Oklahoma City, Oklahoma, United States, 73112
Sponsors and Collaborators
Forest Laboratories
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Study Director: Ramesh Boinpally, PhD Forest Research Institute, an affiliate of Allergan plc.
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Responsible Party: Forest Laboratories Identifier: NCT02220348    
Other Study ID Numbers: LIN-PK-01
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020
Keywords provided by Forest Laboratories:
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Signs and Symptoms, Digestive
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents