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

Phase 2

Not yet recruiting

• Conditions: CHRONIC HYPONATREMIA
• Interventions: Drug: Placebo; Drug: nC-001

• Registration Number: NCT06798675
• Lead Sponsor: nephCentric

Brief Summary

CHRONIC EUVOLEMIC HYPONATREMIA

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-27
• Last Update Submitted: 2025-01-27
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
15gm	nC-001	-
30gm	nC-001	-

Primary Outcome Measures

Name	Time	Method
Serum Urea and Sodium (Na)	24 hrs

Secondary Outcome Measures

Name	Time	Method
Safety	15 days	Incidence and severity of treatment-emergent adverse events (TEAE) as assessed by CTCAE v5.0
Tolerability	1 day	Five-Point Palatability Scale; (scores 1-5); 1. Very Bad; 2. Bad; 3. Neutral; 4. Good; 5. Very Good