A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease

Study Overview
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Brief Summary
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This two-part study will evaluate how safe LY3154207 is and the effects it has on the body. Part A will include healthy participants. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part A will last approximately 4 weeks including a 17 day stay in the clinical research unit (CRU) and follow-up. Part B is contingent on the results of Part A. Part B will include participants with Parkinson's disease. Each participant will receive daily doses of LY3154207 or placebo for 14 days. Part B will last approximately 4 weeks including a 17 day stay in the CRU and follow-up. Both Part A and Part B will require screening within 30 days prior to the start of the study.

Official Title
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Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: LY3154207
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Part A: Overtly healthy males or females, as determined by medical history and physical examination Female participants not of child-bearing potential Part B: Have a clinical diagnosis of idiopathic Parkinson's disease for at least 1 year and on stable medication for at least 4 weeks Part A and B 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 18.0 to 29.9 kilograms per square meter (kg/m²) Exclusion Criteria: Have participated, in the last 30 days, in a clinical trial involving an investigational product Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; or constituting a risk when taking the study medication; or interfering with the interpretation of study data

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3154207<br>LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days. | Drug: LY3154207<br>* Administered orally<br>|
| Placebo Comparator: Placebo<br>Placebo matching LY3154207 administered once daily for 14 days. | Drug: Placebo<br>* Administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |  | Baseline through study completion (Day 15) in each part. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207 |  | At multiple time points from baseline through day 15 in each part | 
| Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 |  | At multiple time points from baseline through day 15 in each part | 
| Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207 after a High-Calorie Meal |  | Baseline through 24 hours after administration of study drug on Day 10 in Part A. | 
| Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 after a High-Calorie Meal |  | Baseline through 24 hours after administration of study drug on Day 10 in Part A. |