Clinical trial NCT04680767: A Study of LY3502970 in Healthy Male Participants
Official title: Disposition of [¹⁴C]-LY3502970 Following Oral Administration in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 6
Sex: MALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).


Eligibility criteria: 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)

Primary outcomes:
measure: Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 17 after administration of study drug
measure: Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
timeFrame: Predose up to Day 17 after administration of study drug
Secondary outcomes:
measure: Plasma Pharmacokinetics (PK): Area under the Concentration-Time Curve (AUC) of LY3502970
timeFrame: Predose up to Day 17 after administration of study drug
measure: Plasma PK: Maximum Concentration (Cmax) of LY3502970
timeFrame: Predose up to Day 17 after administration of study drug
measure: Plasma and Whole Blood PK of Radioactivity: AUC
timeFrame: Predose up to Day 17 after administration of study drug
measure: Plasma and Whole Blood PK of Radioactivity: Cmax
timeFrame: Predose up to Day 17 after administration of study drug
measure: Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine
timeFrame: Predose up to Day 17 after administration of study drug
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: