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

Bausch Health Americas, Inc.7 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Idiopathic Constipation

Interventions

PlecanatideDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Synergy Research Center 002

North Hollywood, California, United States

Syergy Research Center 003

Tamarac, Florida, United States

Synergy Research Center 001

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

Cmax,ss of TRULANCE (plecanatid) and its active metabolite in breast milk

Maximum observed concentration of TRULANCE (plecanatide) in breast milk during a dosing interval at steady state

Time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)

Cavg,ss of TRULANCE (plecanatide) and its active metabolite in breast milk

Average concentration of TRULANCE (plecanatide) in breast milk at steady state

Time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)

AUCτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk

Area under the concentration-time curve during a dosing interval at steady state interval at steady state

Time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)

Aτ,ss of TRULANCE (plecanatide) and its active metabolite in breast milk

Amount (of unchanged drug) excreted into the milk during a dosing interval at steady state a dosing interval (τ) at steady state

Time frame: Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)

Data from ClinicalTrials.gov

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