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

• Status: Completed
• Trial end date: 2019-05-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Forest Laboratories
• Treatments: Linaclotide

Criteria

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