Menu
Not yet recruiting NCT06798675

Phase 2a Study for PK/PD of nC-001

Phase II Interventional CHRONIC HYPONATREMIA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: nC-001, Placebo.
Who it may be relevant to
Registry conditions: CHRONIC HYPONATREMIA. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE-RANGING CLINICAL TRIAL TO EVALUATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF nC-001 IN PATIENTS WITH CHRONIC EUVOLEMIC HYPONATREMIA

Overview

CHRONIC EUVOLEMIC HYPONATREMIA

Interventions

  • Drug nC-001
    solid dosage form single dose
  • Drug Placebo
    Placebo

Primary outcome measures

  • Serum Urea and Sodium (Na) [Time frame: 24 hrs]
Secondary outcome measures (2)
  • Safety [Time frame: 15 days]
  • Tolerability [Time frame: 1 day]

Eligibility criteria

Inclusion criteria

  • Men or women ≥18 and ≤85 years of age
  • Diagnosis of chronic euvolemic hyponatremia

Exclusion criteria

  • 1\. Hyponatremia assessed by the Investigator to be hypervolemic, hypovolemic, or due to psychogenic polydipsia

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06798675 · PNC-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗