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

Chronic Idiopathic Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551873
• Other study ID #: SP304-3117-14
• Status: Completed
• Start date: June 21, 2018
• Est. completion date: December 14, 2018

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

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.

Locations

Country	Name	City	State
United States	Synergy Research Center 002	North Hollywood	California
United States	Synergy Research Center 001	Raleigh	North Carolina
United States	Syergy Research Center 003	Tamarac	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	AUCt,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)
Primary	At,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 (t) at steady state	Day 1 (pre-dose [1 hour before dosing], at 2, 6 and 12 hours post-dose)