A Lactation Study in Women Who Are Breastfeeding or Pumping and Are Receiving Linaclotide Therapeutically (LIN-PK-01)

Forest Laboratories

Status and phase: Completed; Phase 1

Conditions: Irritable Bowel Syndrome; Breast Feeding; Constipation

Treatments: Drug: linaclotide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02220348

LIN-PK-01

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

linaclotide

Experimental group

Description:

Linaclotide 72μg, 145 μg, or 290 μg capsules, once daily for 3 days, oral administration

Treatment:

Drug: linaclotide