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A Safety Study of LY3526318 in Healthy Participants

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: NCT04682119
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : June 10, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3526318 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants
Actual Study Start Date : December 29, 2020
Actual Primary Completion Date : April 21, 2021
Actual Study Completion Date : April 21, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3526318 (Part A)
LY3526318 administered orally as single ascending doses.
 Drug: LY3526318
Administered orally.
Experimental: LY3526318 (Part B)
LY3526318 administered orally as multiple doses.
 Drug: LY3526318
Administered orally.
Placebo Comparator: Placebo (Part A)
Placebo administered orally.
 Drug: Placebo
Administered orally.
Placebo Comparator: Placebo (Part B)
Placebo administered orally.
 Drug: Placebo
Administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318 [ Time Frame: Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8 ]
    PK: AUC of LY3526318

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3526318 [ Time Frame: Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8 ]
    PK: Cmax of LY3526318


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, as determined through medical history and physical examination
  • Have a body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²)
  • Have clinical laboratory test results within normal reference range

Exclusion Criteria:

  • Have a history or presence of medical illness including, but not limited to, cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
  • Have an abnormality in the 12-lead electrocardiogram (ECG)
  • Have a history of clinically significant multiple or severe drug allergies
  • Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen.
  • Have an abnormal blood pressure
  • Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
  • Are unwilling to stop herbal supplements, over the counter or prescription medicines
  • Are currently enrolled in a clinical drug study or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Participants with a history of drug abuse
Contacts and Locations
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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): NCT04682119


Locations
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Netherlands
PRA Health Sciences
Groningen, Netherlands, 9728
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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04682119    
Other Study ID Numbers: 17807
2020-004290-46 ( EudraCT Number )
J2D-MC-CVAC ( Other Identifier: Eli Lilly and Company )
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No