A Study of LY3502970 in Healthy Male Participants

Healthy Clinical Trial

Official title:

Disposition of [¹⁴C]-LY3502970 Following Oral Administration in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04680767
• Other study ID #: 17784
• Secondary ID: J2A-MC-GZGF2020-
• Status: Completed
• Phase: Phase 1
• Start date: March 29, 2021
• Est. completion date: July 3, 2021

Study information

• Verified date: July 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 3, 2021
• Est. primary completion date: July 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3502970
Administered orally.
• [¹4C]-LY3502970
Administered orally.

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	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
Primary	Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	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
Secondary	Plasma Pharmacokinetics (PK): Area under the Concentration-Time Curve (AUC) of LY3502970	Plasma PK: AUC of LY3502970	Predose up to Day 17 after administration of study drug
Secondary	Plasma PK: Maximum Concentration (Cmax) of LY3502970	Plasma PK: Cmax of LY3502970	Predose up to Day 17 after administration of study drug
Secondary	Plasma and Whole Blood PK of Radioactivity: AUC	Plasma and Whole Blood PK of Radioactivity: AUC	Predose up to Day 17 after administration of study drug
Secondary	Plasma and Whole Blood PK of Radioactivity: Cmax	Plasma and Whole Blood PK of Radioactivity: Cmax	Predose up to Day 17 after administration of study drug
Secondary	Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine	Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine	Predose up to Day 17 after administration of study drug