Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06203444
Status:
COMPLETED
Last Update Posted:
2024-07-11
First Post:
2023-12-17
Brief Title:
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
Sponsor:
Ardelyx
Organization:
Ardelyx
Study Overview
Official Title:
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects
Detailed Description:
This will be an open-label study to investigate the PK of tenapanor and AZ13792925 in breast milk of lactating female subjects Potential subjects will be screened to assess their eligibility to enter the study within 15 days prior to the first dose administration Subjects will receive tenapanor from Days 1 to 4 and will be monitored for 24 hours after the last dose of tenapanor On Day 4 breast milk to evaluate concentrations of tenapanor and AZ13792925 will be collected pre-dose Hour 0 1 2 4 6 8 and 24 hours post-dose Subjects will return for a Follow-up visit 5 to 7 days Day 101 after the last dose All breast milk not used for PK analyses will be discarded not fed to infant starting on Day 1 after the first dose of tenapanor is administered until Day 7 72 hours after last dose of tenapanor
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None