Chronic Idiopathic Constipation Clinical Trial
Official 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
Verified date | November 2019 |
Source | Bausch Health Americas, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a multi-center, open-label study evaluating pharmacokinetics of TRULANCE® (plecanatide) in breast milk of lactating women treated with TRULANCE
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. |
United States,
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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