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

NCT03551873 | Completed FDA Drug

• 1 other identifier: SP304-3117-14
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Chronic Idiopathic Constipation

Keywords

Breast milk; Lactating

Outcome Measures

Primary Outcomes (4)

• 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)

Interventions

Plecanatide DRUG

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.

Also known as: TRULANCE®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (3)

Synergy Research Center 002

North Hollywood, California, 91606, United States

Location

Syergy Research Center 003

Tamarac, Florida, 33319, United States

Location

Synergy Research Center 001

Raleigh, North Carolina, 27612, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Breast milk

MeSH Terms

Interventions

plecanatide

Study Officials

• Anhthu Nguyen

  Synergy Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2018
• First Posted: June 11, 2018
• Study Start: June 21, 2018
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

US (3)