RecruitingPhase 1Phase 2NCT05994534

PK and PD Study of NPI-001 and Cysteamine Bitartrate

A Phase 1/2 Pharmacokinetic and Pharmacodynamic Study of NPI-001 Oral Solution Compared to Cysteamine Bitartrate in Cystinosis Patients


Sponsor

Nacuity Pharmaceuticals, Inc.

Enrollment

12 participants

Start Date

Oct 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients compared with cysteamine.


Eligibility

Min Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cysteamine Bitartrate and a drug called N-Acetylcysteine Amide for people with cystinosis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 10 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCysteamine Bitartrate

Single dose, tablets at current therapeutic dose

DRUGN-Acetylcysteine Amide

Single dose, oral solution


Locations(1)

Children's Hospital at Westmead

Westmead, New South Wales, Australia

View Full Details on ClinicalTrials.gov

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NCT05994534


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