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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02562768
• Date of registration: 28/09/2015
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
• Scientific title: Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's Disease
• Date of first enrolment: September 30, 2015
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02562768
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: LY3154207

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 after a High-Calorie Meal [Time Frame: Baseline through 24 hours after administration of study drug on Day 10 in Part A.]

Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 [Time Frame: 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 [Time Frame: 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 [Time Frame: At multiple time points from baseline through day 15 in each part]

Secondary ID(s)

I7S-EW-HBEC

15512

Source(s) of Monetary Support

Please refer to primary and secondary sponsors