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A Phase I, Cross-over Study Comparing the Relative Bioavailability of Laroprovstat Plus Ezetimibe Fixed Combination Drug Products Versus Their Single Therapy Products in Healthy Adults

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary and study completion dates changed from estimate of Sep 7, 2026 to Sep 6, 2026 · Interventions: Ezetimibe STP (Drug), Laroprovstat STP (Drug), Laroprovstat/ezetimibe FCDP (Drug), Laroprovstat/ezetimibe FCDP-slow variant (Drug) to Ezetimibe STP (Drug), Laroprovstat STP (Drug), Laroprovstat/ezetimibe FCDP (Drug), Laroprovstat/ezetimibe FCDP-slow variant (Drug) · Eligibility criteria expanded, about 9 words · 2 more Show 5 more changesShow less
    • Primary and study completion dates changed from estimate of Sep 7, 2026 to Sep 6, 2026
    • Interventions: Ezetimibe STP (Drug), Laroprovstat STP (Drug), Laroprovstat/ezetimibe FCDP (Drug), Laroprovstat/ezetimibe FCDP-slow variant (Drug) to Ezetimibe STP (Drug), Laroprovstat STP (Drug), Laroprovstat/ezetimibe FCDP (Drug), Laroprovstat/ezetimibe FCDP-slow variant (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description expanded, about 4 words
  2. Enrollment closed, study ongoing Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  3. Recruitment opened Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  4. Study Status, Referencesv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AstraZeneca
727 trials monitored
See 61 trials at risk
The purpose of this study is to assess how well laroprovstat and ezetimibe combined in a single tablet to be taken by mouth works and what the body does to the drug (pharmacokinetics) compared with laroprovstat and ezetimibe individual tablets to be taken by mouth (relative bioavailability) as well as to see if there is any effect of eating compared to fasting (food effect) in healthy adults.
Trial Details
NCT Number NCT07622433
Lead Sponsor AstraZeneca
Conditions Healthy Participants
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov