NCT03551873

A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®

A Phase 4 Open-label, Non-randomized Study Evaluating the Pharmacokinetics and Safety of TRULANCE® (Plecanatide) in Breast Milk of Lactating Women Treated With TRULANCE

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE

Detailed description

This is an open-label study in lactating women who have been prescribed TRULANCE® by their healthcare provider. The study will assess the pharmacokinetics of plecanatide and its active metabolite in breast milk of lactating women treated therapeutically with TRULANCE. Subjects will be screened prior to admission for Baseline assessments. Following final qualifications, the morning dose of TRULANCE will be administered under supervision from study personnel and serial samples of breast milk will be collected via breast pump.

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	Plecanatide	Subjects will have been breastfeeding or pumping for at least 4 weeks and must have been prescribed and taking TRULANCE® for at least 14 continuous days prior to Baseline. Breast milk for measurement of TRULANCE® (plecanatide) concentrations will be collected at Day 1.

Timeline

• Start date: 2018-06-21
• Primary completion: 2018-12-14
• Completion: 2018-12-14
• First posted: 2018-06-11
• Last updated: 2019-11-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study