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

Phase 1

Completed

• Conditions: Lactation
• Interventions: Drug: Tenapanor

• Registration Number: NCT06203444
• Lead Sponsor: Ardelyx

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 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 Timeline

• Study Start: 2023-11-27
• Study First Submitted: 2023-12-17
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-12
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Tenapanor	Eligible subjects will be enrolled to receive the study drug

Primary Outcome Measures

Name	Time	Method
Concentration of tenapanor and its major metabolite in breast milk	26 Days	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.

Secondary Outcome Measures

Name	Time	Method
The safety of tenapanor in lactating females	26 Days	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.

Trial Locations

Locations (2)

Fortrea Clinical Research Unit; 🇺🇸 Madison, Wisconsin, United States

DDSI; 🇺🇸 Oklahoma City, Oklahoma, United States