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

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06798675
Enrollment
24
Registered
2025-01-29
Start date
2025-08-31
Completion date
2026-06-30
Last updated
2025-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHRONIC HYPONATREMIA

Brief summary

CHRONIC EUVOLEMIC HYPONATREMIA

Interventions

DRUGnC-001

solid dosage form single dose

DRUGPlacebo

Placebo

Sponsors

nephCentric
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Serum Urea and Sodium (Na)24 hrs

Secondary

MeasureTime frameDescription
Safety15 daysIncidence and severity of treatment-emergent adverse events (TEAE) as assessed by CTCAE v5.0
Tolerability1 dayFive-Point Palatability Scale; (scores 1-5) 1. Very Bad 2. Bad 3. Neutral 4. Good 5. Very Good

Contacts

Primary ContactPriti Kaur
480-287-1610

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026