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

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Digestive Disease Specialists Inc (DDSI)

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
Drug: linaclotide
Other Names:
  • Linzess

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
From Baseline (Day 1) to Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

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

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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