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

Part of paid clinical trials in Lenexa, Kansas.

Sponsor
Eli Lilly and Company
Study ID
NCT07662798
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Tersolisib — DRUG
    Tersolisib administered orally
  • High-fat Meal — OTHER
    High-fat Meal
  • Low-fat Meal — OTHER
    Low-fat Meal

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Group 1 Treatment A Fasted
    Tersolisib administered orally.
  • Experimental: Group 1 Treatment B High-Fat Meal
    Tersolisib administered orally.
  • Experimental: Group 2 Treatment A Fasted
    Tersolisib administered orally.
  • Experimental: Group 2 Treatment C Low-Fat Meal
    Tersolisib administered orally.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib [ Time Frame: Predose on Day 1 Through Day 28 ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (2)

FacilityCityStateZIPSite coordinators
Lenexa ClinicLenexaKansas66219-
ICON Early Phase Services, LLCSan AntonioTexas78232-

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Lenexa Clinic· Lenexa, KSICON Early Phase Services, LLC· San Antonio, TX

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