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PK and PD Study of NPI-001 and Cysteamine Bitartrate

NCT05994534 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-13

No results posted yet for this study

Summary

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

Conditions

  • Cystinosis

Interventions

DRUG

Cysteamine Bitartrate

Single dose, tablets at current therapeutic dose

DRUG

N-Acetylcysteine Amide

Single dose, oral solution

Sponsors & Collaborators

  • Nacuity Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Hugh McCarthy, PhD, FRACP · Sydney Children's Health Network

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-29
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05994534 on ClinicalTrials.gov