A Study of LY3323795 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3323795; Drug: Itraconazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02989389

I9F-MC-SCAA (Other Identifier)

16610

Details and patient eligibility

About

The main purpose of this study is to investigate the safety of LY3323795 and the effects it has on the body. The study drug or placebo (sugar pill) will be given by mouth to healthy participants. The study has three parts. Each participant may only enroll in one part. The study will last 14 to 43 days, depending on the part. Screening must be completed prior to study start.

Enrollment: 42 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males or females of non-childbearing potential at time of screening
• Have a body mass index (BMI) between 18.0 kilograms per square meter (kg/m²) and 32.0 kg/m², inclusive

Exclusion criteria

• Have participated, within the last 30 days, in a clinical trial involving an investigational product.
• Have a QT corrected for heart rate (QTc) (using Bazett's formula) interval value of greater than 450 millisecond (msec) (males) or greater than 470 msec (females)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 6 patient groups, including a placebo group

LY3323795 (Part A)

Experimental group

Description:

Participants received escalating doses of 0.3 mg (milligrams), 1 mg, 3 mg, 10 mg, 30 mg and 100 mg of LY3323795 orally.

Treatment:

Drug: LY3323795

Placebo (Part A)

Placebo Comparator group

Description:

Participants received placebo identical to LY3323795 orally.

Treatment:

Drug: Placebo

LY3323795 (Part B)

Experimental group

Description:

Participants received 6 mg, 20 mg and 80 mg of LY3323795 orally.

Treatment:

Drug: LY3323795

Placebo (Part B)

Placebo Comparator group

Description:

Participants received placebo identical to LY3323795 orally.

Treatment:

Drug: Placebo

LY3323795 (Part C)

Experimental group

Description:

Part C was not initiated due to a Lilly internal strategy decision.

Treatment:

Drug: LY3323795

LY3323795 + Itraconazole (Part C)

Experimental group

Description:

Part C was not initiated due to a Lilly internal strategy decision.

Treatment:

Drug: Itraconazole

Drug: LY3323795