A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically

Last updated: December 16, 2020
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

1

Condition

Gastrointestinal Diseases And Disorders

Breast Feeding

Lactose Intolerance

Treatment

N/A

Clinical Study ID

NCT02220348
LIN-PK-01
  • Ages 18-45
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Be a lactating female who has been actively breastfeeding or pumping for at least 4weeks
  • Be already taking linaclotide therapeutically for Irritable Bowel Syndrome withConstipation (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 supplyand discontinue breastfeeding for the 24-hour period of breast milk collection

Exclusion

Exclusion Criteria:

  • Clinically significant disease state in any body system, except for the indicationbeing treated with linaclotide
  • Any structural abnormality of the gastrointestinal (GI) tract, or a disease orcondition that can affect GI motility
  • Participation in any other clinical investigation using an experimental drug within 90days

Study Design

Total Participants: 7
Study Start date:
July 31, 2014
Estimated Completion Date:
May 31, 2019

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Digestive Disease Specialists Inc (DDSI)

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Temple University Hospital

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

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