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

Phase 1

Completed

• Conditions: Breast Feeding; Constipation; Irritable Bowel Syndrome
• Interventions: Drug: linaclotide

• Registration Number: NCT02220348
• Lead Sponsor: Forest Laboratories

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-31
• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-16
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
linaclotide	linaclotide	Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration

Primary Outcome Measures

Name	Time	Method
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk	From Baseline (Day 1) to Day 4

Trial Locations

Locations (2)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Digestive Disease Specialists Inc (DDSI); 🇺🇸 Oklahoma City, Oklahoma, United States