NCT06798675

Brief Summary

CHRONIC EUVOLEMIC HYPONATREMIA

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
1mo left

Started Aug 2025

Shorter than P25 for phase_2

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Aug 2025Jun 2026

First Submitted

Initial submission to the registry

January 7, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

7 months

First QC Date

January 7, 2025

Last Update Submit

May 22, 2025

Conditions

CHRONIC HYPONATREMIA

Outcome Measures

Primary Outcomes (1)

  • Serum Urea and Sodium (Na)

    24 hrs

Secondary Outcomes (2)

  • Safety

    15 days

  • Tolerability

    1 day

Study Arms (3)

15gm

ACTIVE COMPARATOR
Drug: nC-001

30gm

ACTIVE COMPARATOR
Drug: nC-001

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

nC-001DRUG

solid dosage form single dose

15gm30gm
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Priti Kaur

CONTACT

480-287-1610

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2025

First Posted

January 29, 2025

Study Start

August 1, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05