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

May 22, 2025 updated by: nephCentric

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

CHRONIC EUVOLEMIC HYPONATREMIA

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Priti Kaur
  • Phone Number: 480-287-1610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men or women ≥18 and ≤85 years of age
  2. Diagnosis of chronic euvolemic hyponatremia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Active Comparator: 15gm
Drug: nC-001
solid dosage form single dose
Active Comparator: 30gm
Drug: nC-001
solid dosage form single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum Urea and Sodium (Na)
Time Frame: 24 hrs
24 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 15 days
Incidence and severity of treatment-emergent adverse events (TEAE) as assessed by CTCAE v5.0
15 days
Tolerability
Time Frame: 1 day

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

  1. Very Bad
  2. Bad
  3. Neutral
  4. Good
  5. Very Good
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

nephCentric

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2025

Last Update Submitted That Met QC Criteria

May 22, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNC-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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