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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.

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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

FieldValue
Enrollment Target 5 participants
Start Date 2020-07-23
Est. Completion 2021-05-25
Phase Phase 1

Sponsor

Chugai Pharmaceutical

17 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.