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A Safety Study of LY3526318 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT04682119
Collaborator
(none)
16
Enrollment
1
Location
4
Arms
3.7
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Dec 29, 2020
Actual Primary Completion Date :
Apr 21, 2021
Actual Study Completion Date :
Apr 21, 2021

Arms and Interventions

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

Primary Outcome Measures

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

    PK: Cmax of LY3526318

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 PRA Health Sciences Groningen Netherlands 9728

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04682119
Other Study ID Numbers:
  • 17807
  • 2020-004290-46
  • J2D-MC-CVAC
First Posted:
Dec 23, 2020
Last Update Posted:
Jun 10, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 10, 2021