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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02562768
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.


Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: LY3154207 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3154207
LY3154207 administered orally once daily in multiple-ascending dose cohorts for 14 days.
Drug: LY3154207
Administered orally

Placebo Comparator: Placebo
Placebo matching LY3154207 administered once daily for 14 days.
Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. Plasma (blood) Pharmacokinetics: Maximum Concentration (Cmax) of LY3154207 [ Time Frame: At multiple time points from baseline through day 15 in each part ]
  3. 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. ]
  4. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, California
Parexel International LLC
Glendale, California, United States, 91206
United States, Florida
Compass Research
Orlanda, Florida, United States, 32806
Compass Research
The Villages, Florida, United States, 32162
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02562768     History of Changes
Other Study ID Numbers: 15512
I7S-EW-HBEC ( Other Identifier: Eli Lilly and Company )
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: March 21, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases