A Study of LY3502970 in Healthy Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT03929744
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • LY3502970 — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.
  • Atorvastatin — DRUG
    Administered orally.
  • Simvastatin — DRUG
    Administered orally.
  • Midazolam — DRUG
    Administered orally.

Study Details

The main purposes of this study are to determine: * The safety of LY3502970 and any side effects that might be associated with it. * How much LY3502970 gets into the bloodstream and how long it takes the body to get rid of it. This study has 5 parts (A, B, C, D, and E). Parts A and D involve a single dose of LY3502970 and will last about 15 days. Part B and E involve multiple doses of LY3502970 and will last about 4 weeks. Part C involves two single doses of LY3502970 and will last about 29 days. Each participant will enroll in only one part. Screening must be completed within 28 days before study start. This study is for research purposes only, and is not intended to treat any medical condition.

Key Dates

Start date
Jun 12, 2019
Status verified
Nov 2020
Primary completion
Nov 2, 2020
Completion
Nov 2, 2020

Study Design

Enrollment
133 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: LY3502970 (Part A)
    Single dose of LY3502970 administered orally.
  • Placebo Comparator: Placebo (Part A)
    Single dose of placebo administered orally.
  • Experimental: LY3502970 (Part B)
    Multiple doses of LY3502970 administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
  • Placebo Comparator: Placebo (Part B)
    Multiple doses of placebo administered orally. Some participants will also receive atorvastatin and simvastatin or midazolam administered orally.
  • Experimental: LY3502970 (Part C)
    Single dose of LY3502970 administered orally in each of two study periods.
  • Experimental: LY3502970 (Part D)
    Single dose of LY3502970 administered orally.
  • Placebo Comparator: Placebo (Part D)
    Single dose of placebo administered orally.
  • Experimental: LY3502970 Formulation 1 (Part E)
    Multiple doses of LY3502970 - formulation 1 administered orally.
  • Experimental: LY3502970 Formulation 2 (Part E)
    Multiple doses of LY3502970 - formulation 2 administered orally.

Primary Outcome Measure

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [ Time Frame: Baseline up to Day 42 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance DallasDallasTexas75247-

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