Phase 2a Study for PK/PD of nC-001 | NCT06798675

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

NCT06798675

Sponsor

nephCentric

Status

Not yet recruiting

Last Update Posted

May 29, 2025Actual

Enrollment

24Estimated

Phase

Phase 2

Conditions

CHRONIC HYPONATREMIA

Interventions

nC-001
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2025Estimated

Primary Completion Date

Mar 2026Estimated

Completion Date

Jun 2026Estimated

First Submitted Date

Jan 7, 2025

First Submission Date that Met QC Criteria

Jan 27, 2025

First Posted Date

Jan 29, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2025

Last Update Posted Date

May 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
15gm	Active Comparator	Drug: nC-001
30gm	Active Comparator	Drug: nC-001
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nC-001	Drug	solid dosage form single dose	15gm 30gm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum Urea and Sodium (Na)		24 hrs

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided