A Phase 1 interventional study of linaclotide in Breast Feeding, Constipation and Irritable Bowel Syndrome, sponsored by Forest Laboratories. Completed at 2 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-12-19.
Sponsored by Forest Laboratories (part of AbbVie) · Phase 1, Interventional, and Other
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.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's enrollment of 7 is below the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →Forest Laboratories is the lead sponsor of 168 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
First submitted before Forest Laboratories became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration
Drug: linaclotide
Also known as: Linzess
Amount of linaclotide and its active metabolite (MM-419447) excreted in breast milk
Time frame: From Baseline (Day 1) to Day 4
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Linaclotide