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

Phase 1CompletedNCT02220348

Forest Laboratories7 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Feeding Constipation Irritable Bowel Syndrome

Interventions

linaclotideDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (2)

University of Iowa

Iowa City, Iowa, United States

Digestive Disease Specialists Inc (DDSI)

Oklahoma City, Oklahoma, United States

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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