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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Drug: Placebo; Drug: LY3154207

• Registration Number: NCT02562768
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-09-28
• Study First Posted: 2015-09-29
• Study Start: 2015-09-30
• Status Verified: 2017-03
• Primary Completion: 2017-03-03
• Study Completion: 2017-03-03
• Last Update Submitted: 2017-03-20
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo matching LY3154207 administered once daily for 14 days.
LY3154207	LY3154207	LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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: 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 after a High-Calorie Meal	Baseline through 24 hours after administration of study drug on Day 10 in Part A.

Trial Locations

Locations (2)

Parexel International LLC; 🇺🇸 Glendale, California, United States

Compass Research; 🇺🇸 The Villages, Florida, United States