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

Completed

• Conditions: Chronic Idiopathic Constipation

• Registration Number: NCT03551873
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2018-04-19
• Study First Submitted QC: 2018-06-07
• Study First Posted: 2018-06-11
• Study Start: 2018-06-21
• Primary Completion: 2018-12-14
• Study Completion: 2018-12-14
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

Inclusion Criteria

• Females ≥ 18 years of age
• Has been breastfeeding or actively pumping for at least 4 weeks
• Has been prescribed TRULANCE by a healthcare provider and has taken it for a minimum of 14 consecutive days before anticipated Baseline Visit
• Has the ability to understand and communicate the requirements of the study and is willing to continue breastfeeding or regular pumping in order to maintain milk supply for the duration of the study
• Weaning must not be underway

Exclusion Criteria

• Has clinically significant medical or psychiatric condition (as determined by the Medical Monitor) other than the medical condition being treated with TRULANCE
• Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
• Has participated in an investigational drug study within the 90 days prior to CRU admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk	Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)	Amount (of unchanged drug) excreted into the milk during a dosing interval at steady state a dosing interval (τ) at steady state
Cavg,ss of TRULANCE (plecanatide) and its active metabolite in breast milk	Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)	Average concentration of TRULANCE (plecanatide) in breast milk at steady state
Cmax,ss of TRULANCE (plecanatid) and its active metabolite in breast milk	Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)	Maximum observed concentration of TRULANCE (plecanatide) in breast milk during a dosing interval at steady state
AUCτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk	Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)	Area under the concentration-time curve during a dosing interval at steady state interval at steady state

Trial Locations

Locations (3)

Synergy Research Center 001; 🇺🇸 Raleigh, North Carolina, United States

Synergy Research Center 002; 🇺🇸 North Hollywood, California, United States

Syergy Research Center 003; 🇺🇸 Tamarac, Florida, United States