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

First listed
Apr 29, 2019
Start date
Jun 12, 2019
Status verified
Jun 2026
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: Part A 0.3 mg LY3502970
    Participants received a single oral dose of 0.3 milligram (mg) LY3502970.
  • Experimental: Part A 1 mg LY3502970
    Participants received a single oral dose of 1 mg LY3502970.
  • Experimental: Part A 3 mg LY3502970
    Participants received a single oral dose of 3 mg LY3502970.
  • Experimental: Part A 6 mg LY3502970
    Participants received a single oral dose of 6 mg LY3502970.
  • Placebo Comparator: Part A Placebo
    Participants received a single oral dose of Placebo.
  • Placebo Comparator: Part B Placebo
    Participants received oral doses of placebo once daily for 4 weeks.
  • Experimental: Part B: 2 mg LY3502970 (Cohort G)
    Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
  • Experimental: Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
    Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
  • Experimental: Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
    Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
  • Experimental: Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)
    Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
  • Experimental: Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)
    Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week. On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
  • Experimental: Part C: 3 mg LY3502970 (Fasted/Fed)
    Part C of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods.
  • Experimental: Part C: 3 mg LY3502970 (Fed/Fasted)
    Part C of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods.
  • Active Comparator: Part D: 3 mg LY3502970 Prototype Formulation
    Part D of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation.
  • Placebo Comparator: Part D: Placebo Prototype Formulation
    Part D of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of placebo in a controlled-release prototype formulation.
  • Experimental: Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
    Part E of the study is exploratory, conducted to study exploratory objectives. Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week.
  • Experimental: Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
    Part E of the study is exploratory, conducted to study exploratory objectives. Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week.

Primary Outcome Measure

Parts A and B: 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 through Follow-up (up to Day 42) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Covance DallasDallasTexas75247-

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