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NCT02220348 Clinical Trial

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

Irritable Bowel Syndrome Clinical Trial

— LIN-PK-01  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02220348
Other study ID # LIN-PK-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 31, 2014
Est. completion date May 31, 2019

Study information
Verified date December 2020
Source Forest Laboratories
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date May 31, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• linaclotide

Locations
Country Name City State
United States University of Iowa Iowa City Iowa
United States Digestive Disease Specialists Inc (DDSI) Oklahoma City Oklahoma

Sponsors (1)
Lead Sponsor Collaborator
Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk From Baseline (Day 1) to Day 4
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