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

NCT ID: NCT06203444

Last Updated: 2024-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-27
• Study Completion Date: 2024-05-30

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).

Conditions

Lactation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Eligible subjects will be enrolled to receive the study drug

Group Type: EXPERIMENTAL

Tenapanor

Intervention Type: DRUG

The study drug will be administered in dose of 50 mg bid

Interventions

Tenapanor

The study drug will be administered in dose of 50 mg bid

Intervention Type: DRUG

Other Intervention Names

IBSRELA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ardelyx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Edelstein, PhD

Role: STUDY_DIRECTOR

Ardelyx

Locations

DDSI

Oklahoma City, Oklahoma, United States

Fortrea Clinical Research Unit

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

TEN-01-109

Identifier Type: -

Identifier Source: org_study_id