A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT02562768|
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : March 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Drug: LY3154207 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's Disease|
|Actual Study Start Date :||September 30, 2015|
|Actual Primary Completion Date :||March 3, 2017|
|Actual Study Completion Date :||March 3, 2017|
LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.
Placebo Comparator: Placebo
Placebo matching LY3154207 administered once daily for 14 days.
- 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. ]
- 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 ]
- 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: 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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562768
|United States, California|
|Parexel International LLC|
|Glendale, California, United States, 91206|
|United States, Florida|
|Orlanda, Florida, United States, 32806|
|The Villages, Florida, United States, 32162|
|Study Director:||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)||Eli Lilly and Company|