NCT02220348

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Feeding
• Constipation
• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	linaclotide

Timeline

• Start date: 2014-07-31
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2014-08-19
• Last updated: 2020-12-19

Locations

2 sites across 1 country: United States