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Completed

NCT Number: NCT02220348

A Lactation Study in Women Who Are Breastfeeding or Pumping and Are 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.

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Key information

Conditions

Breast Feeding Behavior Colonic Diseases Colonic Diseases, Functional Constipation Digestive System Diseases Feeding Behavior Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University of Iowa, Iowa City, Iowa, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linaclotide

Drug

Other names: Linzess

Primary outcomes

  1. Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk

    Time frame: From Baseline (Day 1) to Day 4

Sponsors and collaborators

Lead sponsor

Forest Laboratories

Industry

Registry information

Official study title

An Open-label, Multiple-dose, Milk-only Lactation Study in Lactating Women Receiving Linaclotide Therapeutically

Acronym: LIN-PK-01

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 19, 2014
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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