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

Completed · Phase 1

Conditions studied: Breast Feeding, Constipation, Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT02220348

Run by

Forest Laboratories

People needed

7

Starts

2014-07-31

Expected to finish

2019-05-31

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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