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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Chronic Idiopathic Constipation

Intervention / Treatment
-----------------
* Drug: Plecanatide


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast milk, Lactating