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OpenTrials
Not Yet Recruiting

NCT Number: NCT06798675

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

CHRONIC EUVOLEMIC HYPONATREMIA

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Key information

Conditions

CHRONIC HYPONATREMIA

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nC-001

Drug

solid dosage form single dose

Placebo

Drug

Placebo

Primary outcomes

  1. Serum Urea and Sodium (Na)

    Time frame: 24 hrs

Secondary outcomes

  1. Safety

    Time frame: 15 days

    Incidence and severity of treatment-emergent adverse events (TEAE) as assessed by CTCAE v5.0

  2. Tolerability

    Time frame: 1 day

    Five-Point Palatability Scale; (scores 1-5)

    • Very Bad
    • Bad
    • Neutral
    • Good
    • Very Good

Study contacts

Contact information is provided by the study sponsor or research team.

Priti Kaur

CONTACT

480-287-1610

Sponsors and collaborators

Lead sponsor

nephCentric

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2025
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.