NCT06203444

An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Ardelyx · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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 10±1) 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).

Conditions

• Lactation

Interventions

Type	Name	Description
DRUG	Tenapanor	The study drug will be administered in dose of 50 mg bid

Timeline

• Start date: 2023-11-27
• Primary completion: 2024-05-30
• Completion: 2024-05-30
• First posted: 2024-01-12
• Last updated: 2024-07-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study