A Multiple Dose Study of LY3502970 in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT05051566
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • LY3502970 — DRUG
    Administered orally.
  • Esomeprazole — DRUG
    Administered orally.

Study Details

The main purpose of this study is to assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.

Key Dates

Start date
Sep 16, 2021
Status verified
Apr 2026
Primary completion
Apr 4, 2022
Completion
Apr 4, 2022

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part A
    * Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 milligrams (mg), increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. * Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 reference oral capsule once daily (QD) * Test Phase/Fasted state (Day 25 to Day 36): On Day 25, participants were randomly assigned to receive 16 mg of LY3502970 QD, either as Prototype 1 tablet or Prototype 2 tablet, and continued through Day 30 (Test Phase 1). On Day 31, participants crossover to the other prototype formulation (i.e., those who initially received prototype 1 now receive prototype 2, and vice versa), continuing through Day 36 (Test Phase 2).
  • Experimental: Part B
    * Dose Titration Phase/Fasted state (Day 1 to Day 18): Participants received single escalating doses of LY3502970 oral capsule every 6 days, starting with a dose of 2 mg, increasing to 4 mg, then 8 mg, and reaching a maximum dose of 16 mg by Day 19. * Reference Phase/Fasted state (Day 19 to Day 24): Participants received 16 mg of LY3502970 prototype 2 tablet QD. * Test Phase 1/Fed state (Day 25 to Day 30): During this phase, participants were administered 16 mg of LY3502970 prototype 2 tablet QD. * Test Phase 2/Fasted state (Day 31 to Day 36): During this phase, participants were administered a PPI 40 mg Esomeprazole tablet first, followed by 16 mg of LY3502970 prototype 2 tablet QD. The PPI was administered to elevate gastric pH (potential of hydrogen), and PK (pharmacokinetic) parameters were evaluated under these elevated gastric pH conditions

Primary Outcome Measure

Part A: PK: Maximum Observed Concentration (Cmax) of LY3502970 Following Multiple Oral Doses of Prototype Formulations Compared to the Reference Formulation [ Time Frame: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose (Days 24, 30 and 36) ]

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