Breast Feeding, Constipation, Irritable Bowel Syndrome
Conditions
Keywords
Linzess
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.
Interventions
DRUGlinaclotide
Sponsors
Forest Laboratories
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk | From Baseline (Day 1) to Day 4 |
Countries
United States
Outcome results
None listed