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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02562768

Enrollment

Registered

2015-09-29

Start date

2015-09-30

Completion date

2017-03-03

Last updated

2017-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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.

Interventions

DRUGLY3154207

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026