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PK and PD Study of NPI-001 and Cysteamine Bitartrate

Study acronym: INCA
StatusCompleted
PhasePhase 1/2
Started
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Record History

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  1. Trial completed Show 4 more changesShow less
    • Final enrollment: 8 participants (planned 12)
    • Primary completion date changed from estimate of Aug 2026 to May 26, 2026
    • Eligibility criteria expanded, about 10 words
    • Site details revised
  2. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from Jun 2026 to Aug 2026
    • Site details revised
    v8
  3. Primary completion date: Jan 2026 to Jun 2026
    • Study completion date: Jan 2026 to Aug 2026
    v7
  4. Primary completion date: Apr 21, 2025 to Jan 2026
    • Study completion date: Jun 21, 2025 to Jan 2026
    v6
  5. Primary completion date: May 21, 2024 to Apr 21, 2025
    • Study completion date: Jun 21, 2024 to Jun 21, 2025
    • Study description shortened, about 4 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Dec 21, 2023 to May 21, 2024
    • Study completion date: Apr 30, 2024 to Jun 21, 2024
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 1, 2023 to Oct 29, 2023
    v3
  3. Primary endpoint revised
    • Study description expanded, about 38 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients compared with cysteamine.
Trial Details
NCT Number NCT05994534
Lead Sponsor Nacuity Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Cystinosis
Related terms Cystinosis
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov