A Study of LY3502970 in Healthy Male Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04680767
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.2
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to eliminate it. This study will involve a single dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to 8 weeks (maximum).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3502970; Drug: [¹⁴C]-LY3502970	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Disposition of [¹⁴C]-LY3502970 Following Oral Administration in Healthy Male Participants
• Actual Study Start Date: Mar 29, 2021
• Actual Primary Completion Date: Jul 3, 2021
• Actual Study Completion Date: Jul 3, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [¹⁴C]-LY3502970 A single dose of LY3502970 and [¹⁴C]-LY3502970 administered orally.	Drug: LY3502970; Administered orally.; Drug: [¹⁴C]-LY3502970; Administered orally.

Outcome Measures

Primary Outcome Measures

1. Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Predose up to Day 17 after administration of study drug]

   Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

2. Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [Predose up to Day 17 after administration of study drug]

   Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Secondary Outcome Measures

1. Plasma Pharmacokinetics (PK): Area under the Concentration-Time Curve (AUC) of LY3502970 [Predose up to Day 17 after administration of study drug]

   Plasma PK: AUC of LY3502970

2. Plasma PK: Maximum Concentration (Cmax) of LY3502970 [Predose up to Day 17 after administration of study drug]

   Plasma PK: Cmax of LY3502970

3. Plasma and Whole Blood PK of Radioactivity: AUC [Predose up to Day 17 after administration of study drug]

   Plasma and Whole Blood PK of Radioactivity: AUC

4. Plasma and Whole Blood PK of Radioactivity: Cmax [Predose up to Day 17 after administration of study drug]

   Plasma and Whole Blood PK of Radioactivity: Cmax

5. Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine [Predose up to Day 17 after administration of study drug]

   Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Are overtly healthy males

• Body weight within 50 and 100 kilograms (kg), inclusive, and body mass index within the range 18.0 and 32.0 kilograms per square meter (kg/m²) (inclusive)

Exclusion Criteria:

• Females

• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product (IP); or of interfering with the interpretation of data

• Have a history of Gilbert's syndrome or have total bilirubin level (TBL) above upper limit of normal (ULN) at screening

• Have evidence of significant active neuropsychiatric disease, as determined by the investigator

• Have had any exposure to LY3502970 or any other glucagon-like peptide-1 (GLP-1) analogs, or other related compounds within the prior 3 months, or any history of allergies to these medications

• Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study

• Have participated, within the last 3 months, in a clinical study involving an IP. If the previous IP has a long half-life, 5 half-lives or 3 months (whichever is longer) should have passed, prior to check-in

• Have participated in any clinical trial involving a radiolabeled IP within 12 months prior to check-in

• Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies

• Show evidence of hepatitis C and/or positive hepatitis C antibody

• Show evidence of hepatitis B and/or positive hepatitis B surface antigen

• Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Covance Clinical Research	Leeds		United Kingdom	LS2 9LH

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: NCT04680767
• Other Study ID Numbers: 17784; J2A-MC-GZGF; 2020-003160-60
• First Posted: Dec 23, 2020
• Last Update Posted: Jul 19, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Jul 19, 2021