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

NCT06203444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-07-11

No results posted yet for this study

Summary

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

Conditions

  • Lactation

Interventions

DRUG

Tenapanor

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

Sponsors & Collaborators

  • Ardelyx

    lead INDUSTRY

Principal Investigators

  • Susan Edelstein, PhD · Ardelyx

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-27
Primary Completion
2024-05-30
Completion
2024-05-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06203444 on ClinicalTrials.gov