LactationPhase 1NCT06203444
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
A Phase 1 study testing Tenapanor in people with Lactation, run by Ardelyx at 2 sites in United States.
Trial summary
This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- What is being tested?
- Tenapanor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Nov 2023to 30 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must satisfy all of the following criteria at the Screening visit unless otherwise stated:
- Females greater than or equal to 18 years of age.
- Body mass index between 18.0 and 35.0 kg/m2, inclusive.
- 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 must be non-pregnant.
- Has been breastfeeding or actively pumping for at least 4 weeks.
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- Willing to continue regular pumping in order to maintain milk supply for the duration of the study.
- Will not feed infant breast milk while taking tenapanor and for 72 hours post the last dose of tenapanor.
- Weaning must not be underway, to ensure an adequate milk supply.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions
Who cannot join
- Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:
- Significant medical or psychiatric disorder, as determined by the Investigator that would interfere with participation.
- 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.
- 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).
- Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
- Loose stools (Type 6 or 7 on the Bristol Stool Form Scale) ≥2 days in the past 7 days
- 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.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fortrea Clinical Research Unit
Madison, Wisconsin, 53704
DDSI
Oklahoma City, Oklahoma, 73112
About this study
This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.
Read the 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
- Being tested
- Tenapanor
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenapanorDrug
Also called IBSRELA
The study drug will be administered in dose of 50 mg bid
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Eligible subjects will be enrolled to receive the study drug Receives: Drug: Tenapanor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of tenapanor and its major metabolite in breast milk
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.
Measured: 26 Days
Secondary outcomes (1)
The safety of tenapanor in lactating females
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.
Measured: 26 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start27 Nov 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open-label study to investigate the PK of tenapanor and AZ13792925 in breast milk of lactating female subjects
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardelyx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susan Edelstein, PhD, Study director, Ardelyx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203444
- Sponsor's protocol ID
- TEN-01-109
- Status last verified
- Jul 2024
- First submitted
- 17 Dec 2023
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
- ClinicalTrials.gov ID
- NCT06203444
- Acronym / sponsor ID
- TEN-01-109
- Conditions
- Lactation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- ArdelyxIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open-label study to investigate the PK of tenapanor and AZ13792925 in breast milk of lactating female subjects
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: TenapanorEligible subjects will be enrolled to receive the study drug |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subjects must satisfy all of the following criteria at the Screening visit unless otherwise stated:
Key exclusion criteria (8 listed)
- Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:
- Significant medical or psychiatric disorder, as determined by the Investigator that would interfere with participation.
- 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.
- 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).
- Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenapanorAlso: IBSRELAThe study drug will be administered in dose of 50 mg bid | Drug | Treatment Arm |
Primary outcome
Concentration of tenapanor and its major metabolite in breast milk
Time frame: 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.
1 secondary outcome
The safety of tenapanor in lactating females
Time frame: 26 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Edelstein, PhD study director
Ardelyx
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenapanor in people with Lactation, run by Ardelyx at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of tenapanor and its major metabolite in breast milk (time frame: 26 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.