A Study of LY3509754 in Healthy Non-Japanese and Japanese Participants

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2022-10-14

Brief Summary

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The main purpose of this study in healthy participants is to learn more about the safety of LY3509754 and any side effects that might be associated with it. Blood tests will be performed to check how much LY3509754 gets into the bloodstream and how long it takes the body to eliminate it.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3509754 - Part A

Escalating doses of 10, 30, 100, 300, 1000, and 2000 milligrams (mg) of LY3509754 were administered orally.

Group Type EXPERIMENTAL

LY3509754

Intervention Type DRUG

Administered orally

Placebo - Part A

Placebo was administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

LY3509754 plus Itraconazole - Part B

10 mg of LY3509754 and 200 mg of Itraconazole were administered orally.

Group Type EXPERIMENTAL

LY3509754

Intervention Type DRUG

Administered orally

Itraconazole

Intervention Type DRUG

Administered orally

Placebo plus Itraconazole - Part B

Placebo and 200 mg Itraconazole were administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Itraconazole

Intervention Type DRUG

Administered orally

LY3509754 plus Midazolam - Part C

Multiple doses of LY3509754 (100, 300, and 1000 mg) were administered orally. Some participants also received 1.2 mg midazolam orally.

Group Type EXPERIMENTAL

LY3509754

Intervention Type DRUG

Administered orally

Midazolam

Intervention Type DRUG

Administered orally

Placebo plus Midazolam - Part C

Multiple doses of placebo were administered orally. Some participants also received 1.2 mg midazolam orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Midazolam

Intervention Type DRUG

Administered orally

LY3509754 (Japanese) - Part D

Multiple doses of LY3509754 (400 and 1000 mg) were administered orally to Japanese participants.

Group Type EXPERIMENTAL

LY3509754

Intervention Type DRUG

Administered orally

Placebo (Japanese) - Part D

Placebo was administered orally to Japanese participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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LY3509754

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Itraconazole

Administered orally

Intervention Type DRUG

Midazolam

Administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Overtly healthy males or females, as determined by medical history and physical examination.
* Body mass index (BMI) within the range of 18 to 35 kilograms per meter squared (kg/m²) in Parts A, B, and C. In Part D (Japanese participants), body weight between 50 and 85 kg and BMI within the range of 18 to 28 kg/m².

Exclusion Criteria

* Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754.
* Women of childbearing potential are excluded from the trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes