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

This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.

Study Overview

• Status: Recruiting
• Conditions: Lactation
• Intervention / Treatment: Drug: Tenapanor

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).

• Study Type: Interventional
• Enrollment (Estimated): 7
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Susan Edelstein, PhD; Phone Number: 510-456-7741; Email: sedelstein@ardelyx.com
• Study Contact Backup: Name: Karishma Raju, MBBS; Phone Number: 510-456-7728; Email: kraju@ardelyx.com

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • DDSI
      • Contact: Lindy Kromer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects must satisfy all of the following criteria at the Screening visit unless otherwise stated:

  1. Females greater than or equal to 18 years of age.
  2. Body mass index between 18.0 and 35.0 kg/m2, inclusive.
  3. In good health with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory as determined by the Investigator.
  4. Females must be non-pregnant.
  5. Has been breastfeeding or actively pumping for at least 4 weeks.
  6. Willing to continue regular pumping in order to maintain milk supply for the duration of the study.
  7. Will not feed infant breast milk while taking tenapanor and for 72 hours post the last dose of tenapanor.
  8. Weaning must not be underway, to ensure an adequate milk supply.
  9. Able to comprehend and willing to sign an ICF and to abide by the study restrictions

Exclusion Criteria:

Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:

1. Significant medical or psychiatric disorder, as determined by the Investigator that would interfere with participation.
2. Use or intend to use any prescription or non-prescription medications 4 days before first dose of tenapanor until Day 6 of the study, unless deemed acceptable by the Investigator and/or Sponsor.
3. History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
4. Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
5. Loose stools (Type 6 or 7 on the Bristol Stool Form Scale) ≥2 days in the past 7 days
6. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or 5 half-lives prior to dosing.
7. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Eligible subjects will be enrolled to receive the study drug	Drug: Tenapanor; The study drug will be administered in dose of 50 mg bid; Other Names: IBSRELA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of tenapanor and its major metabolite in breast milk	The primary objective of the study is to determine the maximum observed milk concentration (Cmax) of tenapanor and its primary metabolite AZ13792925 in the breast milk of lactating female subjects.	26 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety of tenapanor in lactating females	The secondary objective of the study is to assess the the incidence and severity of treatment-emergent adverse events of tenapanor when administered to lactating female subjects.	26 Days

Collaborators and Investigators

• Sponsor: Ardelyx

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): May 8, 2024
• Study Completion (Estimated): May 8, 2024

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: TEN-01-109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No