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Completed

NCT Number: NCT03551873

A Postmarketing Study of 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

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Key information

Conditions

Chronic Idiopathic Constipation

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Synergy Research Center 002, North Hollywood, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: TRULANCE®

Primary outcomes

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

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

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

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

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

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

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

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

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

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

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

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

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 11, 2018
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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