A Multiple-Dose Study of LY3502970 in Healthy Participants
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT05110794
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 21 Years - 70 Years
- Healthy Volunteers
- Accepted
Interventions
- LY3502970 — DRUGAdministered Orally.
Study Details
The main purpose of this study is to conduct blood tests to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in healthy participants in fed and fasted states. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study will last up to 49 days excluding the screening period.
Key Dates
- Start date
- Nov 5, 2021
- Status verified
- Apr 2026
- Primary completion
- Feb 10, 2022
- Completion
- Feb 10, 2022
Study Design
- Enrollment
- 34 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: LY3502970 TitrationDose Titration Period: Participants received increasing doses of LY3502970 administered orally every 7 days on Day 1 to Day 21. Day 1 to Day 8: 2 milligram (mg) LY3502970 every day (QD), Day 8 to Day 15: 4 mg LY3502970 QD, Day 15 to Day 21: 8 mg LY3502970 QD, Participants were randomized to Fasted state or Fed state sequence on Day 22.
- Experimental: LY3502970 (Fasted/Fed)Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fasted state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fed state.
- Experimental: LY3502970 (Fed/Fasted)Test Period 1: Participants received 16 mg LY3502970 administered orally QD, Day 22 to Day 28 in Fed state. Test Period 2: Participants received 16 mg LY3502970 administered orally QD, Day 29 to Day 35 in Fasted state.
Primary Outcome Measure
PK: Maximum Observed Concentration (Cmax) of LY3502970 [ Time Frame: PK: Day 28: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24h Postdose (Test Period 1); Day 35: Predose, 0.5, 1, 2, 4, 6, 8, 12, 16, and 24h Postdose (Test Period 2) ]
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