A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants

StatusCompleted
PhasePhase 1
Started

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Record History

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  1. Trial completed
    • Primary and study completion dates changed from estimate of Sep 2026 to Sep 3, 2026
    • Eligibility criteria expanded, about 14 words
  2. Enrollment closed, study ongoing
    • Site details revised at 2 of 2 sites
    v3
  3. Recruitment opened
    • Start date changed from estimate of Jul 2026 to Jul 1, 2026
    • Site details revised at 2 of 2 sites
    v2
  4. Study First Submitted
  • 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.
Eli Lilly
363 trials monitored
See 16 trials at risk
The main purpose of this study is to measure how food affects the amount of tersolisib that gets into the bloodstream. Each participant will receive two single oral doses of tersolisib, one under fasted conditions and one with either a high-fat or a low-fat meal. Blood tests will be performed to investigate how the body processes the study drug under each condition. For each participant, the study will last about 9 weeks and will include a stay in the Clinical Research Unit (CRU) lasting almost a month.
Trial Details
NCT Number NCT07662798
Lead Sponsor Eli Lilly and Company
Conditions
(from sponsor)		 Healthy
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov