clinical trial · NCT05994534
PK and PD Study of NPI-001 and Cysteamine Bitartrate
Nacuity Pharmaceuticals, Inc.·phase2·recruiting·n = 12
CystinosisCysteamine BitartrateN-Acetylcysteine Amide
brief summary
Safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients compared with cysteamine.
started
Oct 29, 2023
primary completion
Jun 1, 2026
completion
Aug 1, 2026
last updated
Apr 13, 2026
detailed description
This study will examine the safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients, aged ≥ 10 years. The ability of NPI-001 to reduce cystine will be assessed and compared with cysteamine.
official title
A Phase 1/2 Pharmacokinetic and Pharmacodynamic Study of NPI-001 Oral Solution Compared to Cysteamine Bitartrate in Cystinosis Patients
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol