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

NCTNCT03551873Other idSP304-3117-14

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase not stated
Enrollment: 7 participants (actual)
Sponsor: Bausch Health Americas, Inc. · Industry
Design: Not stated
Countries: 1 country
United States
Start: 21 Jun 2018
Primary completion: 14 Dec 2018
Completion: 14 Dec 2018
First posted: 11 Jun 2018
Last update posted: 22 Nov 2019
Conditions: Chronic Idiopathic Constipation

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182019

Ph –
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
NCT03551873
21 Jun 2018 to 14 Dec 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

PlecanatideDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes4

Outcomes the sponsor listed as primary.

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)
Registry description
Maximum observed concentration of TRULANCE (plecanatide) in breast milk during a dosing interval at steady state
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)
Registry description
Average concentration of TRULANCE (plecanatide) in breast milk at steady state
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)
Registry description
Area under the concentration-time curve during a dosing interval at steady state interval at steady state
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)
Registry description
Amount (of unchanged drug) excreted into the milk during a dosing interval at steady state a dosing interval (τ) at steady state

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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