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NCT06203444 · ClinicalTrials.gov registry record · Phase 1
An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females
A Phase 1 study, sponsored by Ardelyx.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT06203444: Completed Phase 1 study, sponsored by Ardelyx.
NCT06203444 is a Phase 1 study that has completed, run by Ardelyx. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06203444, a Phase 1 study, has completed, sponsored by Ardelyx.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.
Primary Outcome
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.
Interventions
- DRUG Tenapanor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 1 |
What the finished NCT06203444 record still lists
NCT06203444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Tenapanor is the first listed.
NCT06203444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06203444 about?
NCT06203444 is a clinical study titled "An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females". This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.
What is the current status of trial NCT06203444?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2023-11-27. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT06203444?
The interventions under investigation include: Tenapanor (DRUG).
Who is sponsoring clinical trial NCT06203444?
This trial is sponsored by Ardelyx, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06203444's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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