A Study of LY3154207 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3154207 (Part A)

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

Group Type EXPERIMENTAL

LY3154207

Intervention Type DRUG

Administered orally

Placebo (Part A)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

LY3154207 (Part B)

LY3154207 administered once orally.

Group Type EXPERIMENTAL

LY3154207

Intervention Type DRUG

Administered orally

Placebo (Part B)

Placebo matching LY3154207 administered once orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

LY3154207 (Part C)

LY3154207 administered once orally on Day 1

Group Type EXPERIMENTAL

LY3154207

Intervention Type DRUG

Administered orally

LY3154207 + Itraconazole (Part C)

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.

Group Type EXPERIMENTAL

LY3154207

Intervention Type DRUG

Administered orally

Itraconazole

Intervention Type DRUG

Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution

Interventions

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LY3154207

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Itraconazole

Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes