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

NCT ID: NCT06798675

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-06-30

Brief Summary

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CHRONIC EUVOLEMIC HYPONATREMIA

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Detailed Description

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Conditions

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CHRONIC HYPONATREMIA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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15gm

Group Type ACTIVE_COMPARATOR

nC-001

Intervention Type DRUG

solid dosage form single dose

30gm

Group Type ACTIVE_COMPARATOR

nC-001

Intervention Type DRUG

solid dosage form single dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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nC-001

solid dosage form single dose

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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nephCentric

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Priti Kaur

Role: CONTACT

480-287-1610

Other Identifiers

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PNC-101

Identifier Type: -

Identifier Source: org_study_id

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