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NCT04209179 · ClinicalTrials.gov registry record · Phase 1
A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism
A Phase 1 study, sponsored by Chugai Pharmaceutical.
- Terminated
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04209179 is a Phase 1 study that was terminated before completion, run by Chugai Pharmaceutical. The registered enrollment target is 5 participants.
The verdict
NCT04209179, a Phase 1 study, was terminated before completion, sponsored by Chugai Pharmaceutical.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment period. The Fixed-Dose Treatment period consists of multiple daily dosing at a fixed dose level. Once patients have completed the Fixed-Dose Treatment period, patients will enter the Dose Titration Treatment period where PCO371 (or placebo), oral calcium and oral active vitamin D can each be titrated according to the patient's albumin-corrected serum calcium level.
Interventions
- DRUG Placebo
- DRUG PCO371
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-07-23 |
| Est. Completion | 2021-05-25 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04209179
The ClinicalTrials.gov registry entry for NCT04209179 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chugai Pharmaceutical, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04209179 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04209179 about?
NCT04209179 is a clinical study titled "A Clinical Study Investigating the Safety, Tolerability, PK and PD of PCO371 in Patients With Hypoparathyroidism". This is a multi-center, placebo-controlled, randomized, double-blind, multiple-ascending dose study in patients with hypoparathyroidism. The total duration of study medication treatment will be 13 weeks and includes a Fixed-Dose Treatment period and a Dose Titration Treatment period. The Fixed-Dose...
What is the current status of trial NCT04209179?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-07-23. Estimated completion is 2021-05-25.
What interventions are being tested in trial NCT04209179?
The interventions under investigation include: Placebo (DRUG), PCO371 (DRUG).
Who is sponsoring clinical trial NCT04209179?
This trial is sponsored by Chugai Pharmaceutical, which has 17 total clinical trials registered on ClinicalTrials.gov.
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