A Study of Two Different Formulations of LY3502970 in Healthy Participants

Sponsor
Eli Lilly and Company
Study ID
NCT05341089
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • LY3502970 — DRUG
    Administered orally.

Study Details

The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream when administered as two different formulations in healthy participants. The study will also evaluate the safety and tolerability of LY3502970. The study will last up to 13 weeks excluding the screening period.

Key Dates

Start date
May 17, 2022
Status verified
Apr 2026
Primary completion
Sep 1, 2022
Completion
Sep 1, 2022

Study Design

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

Arms

  • Experimental: 2 mg/4mg/8mg LY3502970 - Dose Titration Period
    Participants received escalating oral doses of LY3502970 according to the following dosing schedule: * Days 1-7: 2 milligrams (mg) once daily (QD) * Days 8-14: 4 mg QD * Days 15-21: 8 mg QD
  • Experimental: 16 mg LY3502970 (Formulation 1/Formulation 2) - Test Period
    Participants received 16 mg LY3502970 Formulation 1 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 2 orally QD from Days 29-35 in test period 2.
  • Experimental: 16 mg LY3502970 (Formulation 2/Formulation 1) - Test Period
    Participants received 16 mg LY3502970 Formulation 2 orally QD from Days 22-28 in test period 1, followed by 16 mg LY3502970 Formulation 1 orally QD from Days 29-35 in test period 2.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 in Formulation 1 and Formulation 2 [ Time Frame: Test Period 1 (Day 28) and Test Period 2 (Day 35): Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours postdose ]

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