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Treatment Arm for Lactation

Phase 1
Recruiting
Research Sponsored by Ardelyx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Females greater than or equal to 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 days
Awards & highlights

Study Summary

This trial is being conducted to study the levels of two medications, tenapanor and AZ13792925, in breast milk of breastfeeding women.

Who is the study for?
This trial is for lactating women over 18 years old with a BMI of 18.0-35.0, in good health, and not pregnant. Participants must have been breastfeeding or pumping for at least four weeks and agree to pump without feeding their infant breast milk during the study and for three days after the last dose.Check my eligibility
What is being tested?
The study tests how Tenapanor transfers into breast milk when taken orally by healthy lactating women. It's an open-label trial, meaning both researchers and participants know what treatment is being given.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include those commonly associated with oral medications such as digestive issues or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am in good health with no significant medical issues.
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I am a woman aged 18 or older.
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I am not pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration of tenapanor and its major metabolite in breast milk
Secondary outcome measures
The safety of tenapanor in lactating females

Side effects data

From 2021 Phase 4 trial • 333 Patients • NCT04549597
42%
Diarrhea
3%
Covid-19
3%
Pneumonia
2%
Peritonitis
1%
Chest Pain
1%
Hypoglycemia
1%
Hyperkalemia
1%
Fluid Overload
1%
Cerebrovascular Accident
1%
Arteriovenous Fistula Site Infection
1%
Catheter Site Infection
1%
Influenza
1%
Ulna Fracture
1%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2
Cohort 3: Phosphate Binder Naïve
Cohort 1

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Eligible subjects will be enrolled to receive the study drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenapanor
2016
Completed Phase 4
~4030

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ArdelyxLead Sponsor
27 Previous Clinical Trials
6,006 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical study currently open for enrollment?

"Indeed, as reported on clinicaltrials.gov, this investigation is actively seeking eligible participants. The study was initially published on November 27th, 2023 and underwent its most recent update on January 2nd, 2024."

Answered by AI

What level of risk does the treatment arm pose to patients?

"Given the limited available data supporting both safety and efficacy, our team at Power estimates that the Treatment Arm has a safety rating of 1 on a scale from 1 to 3. This is in line with it being classified as a Phase 1 trial."

Answered by AI

Which individuals meet the eligibility criteria to participate in this clinical study?

"In order to be eligible for participation in this trial, potential subjects must exhibit lactation and fall within the age range of 18 to 60. The study has a limited capacity of accepting only 7 individuals."

Answered by AI

Is the age eligibility criteria for this research study limited to individuals below 60 years of age?

"In line with the eligibility criteria for this research, individuals aged 18 or above but below 60 are eligible to participate."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
2023. "An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06203444.
~0 spots leftby May 2024
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