Trials / Recruiting
RecruitingNCT05994534
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- Sponsor
- Nacuity Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Not accepted
Summary
Safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients compared with cysteamine.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cysteamine Bitartrate | Single dose, tablets at current therapeutic dose |
| DRUG | N-Acetylcysteine Amide | Single dose, oral solution |
Timeline
- Start date
- 2023-10-29
- Primary completion
- 2026-06-01
- Completion
- 2026-08-01
- First posted
- 2023-08-16
- Last updated
- 2026-04-13
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT05994534. Inclusion in this directory is not an endorsement.