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
2 other identifiers
interventional
80
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2015
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
September 29, 2015
CompletedStudy Start
First participant enrolled
September 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 3, 2017
CompletedMarch 21, 2017
March 1, 2017
1.4 years
September 28, 2015
March 20, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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.
Study Arms (2)
LY3154207
EXPERIMENTALLY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.
Placebo
PLACEBO COMPARATORPlacebo matching LY3154207 administered once daily for 14 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Parexel International LLC
Glendale, California, 91206, United States
Compass Research
Orlanda, Florida, 32806, United States
Compass Research
The Villages, Florida, 32162, United States
Related Publications (2)
Wilbraham D, Biglan KM, Svensson KA, Tsai M, Pugh M, Ardayfio P, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator, in Patients With Parkinson Disease. Clin Pharmacol Drug Dev. 2022 Mar;11(3):324-332. doi: 10.1002/cpdd.1039. Epub 2021 Oct 19.
PMID: 34664427DERIVEDWilbraham D, Biglan KM, Svensson KA, Tsai M, Kielbasa W. Safety, Tolerability, and Pharmacokinetics of Mevidalen (LY3154207), a Centrally Acting Dopamine D1 Receptor-Positive Allosteric Modulator (D1PAM), in Healthy Subjects. Clin Pharmacol Drug Dev. 2021 Apr;10(4):393-403. doi: 10.1002/cpdd.874. Epub 2020 Oct 7.
PMID: 33029934DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2015
First Posted
September 29, 2015
Study Start
September 30, 2015
Primary Completion
March 3, 2017
Study Completion
March 3, 2017
Last Updated
March 21, 2017
Record last verified: 2017-03