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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562768
• Other study ID #: 15512
• Secondary ID: I7S-EW-HBEC
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2015
• Last updated: March 20, 2017
• Start date: September 30, 2015
• Est. completion date: March 3, 2017

Study information

• Verified date: March 2017
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 3, 2017
• Est. primary completion date: March 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• LY3154207
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
United States	Parexel International LLC	Glendale	California
United States	Compass Research	Orlanda	Florida
United States	Compass Research	The Villages	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207		At multiple time points from baseline through day 15 in each part
Secondary	Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207		At multiple time points from baseline through day 15 in each part
Secondary	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.
Secondary	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.

External Links

•   Click here for more information about this study: A Study of LY3154207 in Participants With Parkinson's Disease (Part B)