Status
Completed
Phase
Not applicable
Enrollment
7
Locations
3
Results
Not posted
Publications
0
Study summary
This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE
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.
Interventions
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.
Timeline
First posted
Jun 11, 2018
Study start
Jun 21, 2018
Primary completion
Dec 14, 2018
Study completion
Dec 14, 2018
Results posted
Not reported
Registry updated
Nov 22, 2019
Outcomes
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
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
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
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
Not reported in the indexed record.
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 locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Synergy Research Center 002
North Hollywood, California, United States
Syergy Research Center 003
Tamarac, Florida, United States
Synergy Research Center 001
Raleigh, North Carolina, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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