A Study of LY3154207 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Itraconazole; Drug: LY3154207; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02365571

I7S-EW-HBEA (Other Identifier)

15510

Details and patient eligibility

About

This study involves single doses of LY3154207 and will evaluate the effects of LY3154207 on the body. There will be 3 parts to this study.

Part A will test single increasing doses of LY3154207 and will last approximately 7 weeks for each participant. Each participant will receive two doses of LY3154207, if part A is completed.

Part B will test a single dose of LY3154207 and will last approximately 5 weeks for each participant. Part B includes collecting fluid from the spinal column to measure levels of LY3154207.

Part C will include a single dose of LY3154207 given alone and then a second dose given along with itraconazole to look for change in LY3154207 levels. Part C will last about 3 weeks for each participant.

Participants may only enroll in 1 of the 3 parts of the study.

Enrollment: 64 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overtly healthy males or females, as determined by medical history and physical examination
• Female participants not of child-bearing potential
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
• Have given written informed consent
• Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m^2)

Exclusion criteria

• Part B only: Have medical or surgical conditions in which lumbar puncture is contraindicated
• Part C only: Have known allergy or contraindications to itraconazole

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

64 participants in 6 patient groups, including a placebo group

LY3154207 (Part A)

Experimental group

Description:

LY3154207 administered in ascending doses once orally in two of three study periods

Treatment:

Drug: LY3154207

Placebo (Part A)

Placebo Comparator group

Description:

Placebo matching LY3154207 administered once orally in one of three study periods.

Treatment:

Drug: Placebo

LY3154207 (Part B)

Experimental group

Description:

LY3154207 administered once orally.

Treatment:

Drug: LY3154207

Placebo (Part B)

Placebo Comparator group

Description:

Placebo matching LY3154207 administered once orally.

Treatment:

Drug: Placebo

LY3154207 (Part C)

Experimental group

Description:

LY3154207 administered once orally on Day 1

Treatment:

Drug: LY3154207

LY3154207 + Itraconazole (Part C)

Experimental group

Description:

Itraconazole administered orally (twice daily on Day 3 and then once daily to Day 12). LY3154207 co-administered once orally, on Day 9. Timing and duration of itraconazole dosing may be adjusted based on data from Part A.

Treatment:

Drug: Itraconazole

Drug: LY3154207