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

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

Study Overview

• Status: Completed
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: Plecanatide

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 Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • California
    • North Hollywood, California, United States, 91606
      • Synergy Research Center 002
  • Florida
    • Tamarac, Florida, United States, 33319
      • Syergy Research Center 003
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Synergy Research Center 001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Lactating women with Chronic idiopathic Constipation (CIC) or Irritable Bowel Syndrome with Constipation (IBS-C)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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)

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Study Director: Anhthu Nguyen, Synergy Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: April 19, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Breast milk; Lactating
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Plecanatide
• Other Study ID Numbers: SP304-3117-14

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes