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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
Ardelyx
Study ID
NCT06203444
Phase
PHASE1
Status
Completed

Conditions

  • Lactation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Tenapanor — DRUG
    The study drug will be administered in dose of 50 mg bid

Study Details

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

Key Dates

Start date
Nov 27, 2023
Status verified
Jul 2024
Primary completion
May 30, 2024
Completion
May 30, 2024

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Eligible subjects will be enrolled to receive the study drug

Primary Outcome Measure

Concentration of tenapanor and its major metabolite in breast milk [ Time Frame: 26 Days ]

Locations (2)

FacilityCityStateZIPSite coordinators
DDSIOklahoma CityOklahoma73112-
Fortrea Clinical Research UnitMadisonWisconsin53704-

Find similar trials in Oklahoma City, OK

By research site
DDSI· Oklahoma City, OKFortrea Clinical Research Unit· Madison, WI

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