A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically
Phase 1
Completed
- Conditions
- Breast FeedingConstipationIrritable Bowel Syndrome
- Interventions
- 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
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What is the excretion pattern of linaclotide and MM-419447 in breast milk after multiple daily doses in lactating women with IBS or constipation?
How does linaclotide's mechanism of action via guanylate cyclase-C receptor activation affect breast milk composition and infant safety?
What are the comparative pharmacokinetics of linaclotide versus other guanylate cyclase-C agonists like plecanatide in lactating populations?
Are there specific biomarkers that correlate with linaclotide concentration gradients in breast milk and maternal plasma?
What adverse event profiles have been observed in lactation studies of gastrointestinal secretagogues including linaclotide?
Trial Locations
- Locations (2)
University of Iowa
🇺🇸Iowa City, Iowa, United States
Digestive Disease Specialists Inc (DDSI)
🇺🇸Oklahoma City, Oklahoma, United States
University of Iowa🇺🇸Iowa City, Iowa, United States