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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3154207
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Parexel International LLC
  • Compass Research
  • Compass Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3154207

Placebo

Arm Description

LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.

Placebo matching LY3154207 administered once daily for 14 days.

Outcomes

Primary Outcome Measures

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Secondary Outcome Measures

Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207
Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207
Plasma (blood) Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3154207 after a High-Calorie Meal
Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 after a High-Calorie Meal

Full Information

First Posted
September 28, 2015
Last Updated
March 20, 2017
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02562768
Brief Title
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
Official Title
Multiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 30, 2015 (Actual)
Primary Completion Date
March 3, 2017 (Actual)
Study Completion Date
March 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3154207
Arm Type
Experimental
Arm Description
LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching LY3154207 administered once daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
LY3154207
Intervention Description
Administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207
Time Frame
At multiple time points from baseline through day 15 in each part
Title
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.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Parexel International LLC
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Compass Research
City
Orlanda
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Compass Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34664427
Citation
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.
Results Reference
derived
PubMed Identifier
33029934
Citation
Wilbraham 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.
Results Reference
derived
Links:
URL
http://www.lillytrialguide.com/en-US/studies/parkinson's-disease/HBEC#?postal=
Description
Click here for more information about this study: A Study of LY3154207 in Participants With Parkinson's Disease (Part B)

Learn more about this trial

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

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