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

Lilly

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: Midazolam; Drug: Placebo; Drug: Itraconazole; Drug: LY3509754

Study type: Interventional

Funder types: Industry

Identifiers

NCT04586920

17797

J3D-MC-FNAA (Other Identifier)

2020-003957-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating LY3509754, and have previously received LY3509754.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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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104 participants in 8 patient groups, including a placebo group

LY3509754 - Part A

Experimental group

Description:

Escalating doses of LY3509754 administered orally

Treatment:

Drug: LY3509754

Placebo - Part A

Placebo Comparator group

Description:

Placebo administered orally

Treatment:

Drug: Placebo

LY3509754 plus Itraconazole - Part B

Experimental group

Description:

LY3509754 and Itraconazole administered orally

Treatment:

Drug: LY3509754

Drug: Itraconazole

Placebo plus Itraconazole - Part B

Placebo Comparator group

Description:

Placebo and Itraconazole administered orally

Treatment:

Drug: Placebo

Drug: Itraconazole

LY3509754 plus Midazolam - Part C

Experimental group

Description:

Multiple doses of LY3509754 administered orally. Some participants will also receive midazolam orally.

Treatment:

Drug: LY3509754

Drug: Midazolam

Placebo plus Midazolam - Part C

Placebo Comparator group

Description:

Multiple doses of placebo administered orally. Some participants will also receive midazolam orally.

Treatment:

Drug: Placebo

Drug: Midazolam

LY3509754 (Japanese) - Part D

Experimental group

Description:

Multiple doses of LY3509754 administered orally to Japanese participants

Treatment:

Drug: LY3509754

Placebo (Japanese) - Part D

Placebo Comparator group

Description:

Placebo administered orally to Japanese participants

Treatment:

Drug: Placebo