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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03551873
Other study ID # SP304-3117-14
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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