A Safety Study of LY3526318 in Healthy Participants

Healthy Clinical Trial

Official title:

A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682119
• Other study ID #: 17807
• Secondary ID: 2020-004290-46J2
• Status: Completed
• Phase: Phase 1
• Start date: December 29, 2020
• Est. completion date: April 21, 2021

Study information

• Verified date: June 1, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 21, 2021
• Est. primary completion date: April 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3526318
Administered orally.
• Placebo
Administered orally.

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3526318	PK: AUC of LY3526318	Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8
Primary	PK: Maximum Observed Drug Concentration (Cmax) of LY3526318	PK: Cmax of LY3526318	Part A: Predose on Day 1 through Day 5; Part B: Predose on Day 1 through Day 8