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

Phase 2Not Yet RecruitingNCT06798675

nephCentric24 enrolled

Overview

CHRONIC EUVOLEMIC HYPONATREMIA

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

CHRONIC HYPONATREMIA

Interventions

nC-001DRUG

solid dosage form single dose

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Serum Urea and Sodium (Na)

Time frame: 24 hrs

Secondary Outcomes

Safety

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

Time frame: 15 days

Tolerability

Five-Point Palatability Scale; (scores 1-5) 1. Very Bad 2. Bad 3. Neutral 4. Good 5. Very Good

Time frame: 1 day

Central Contacts

Priti Kaur

CONTACT

480-287-1610

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.