A Study of LY3337641 in Healthy Male Participants

NCT02914379 | Completed Phase 1 Results

• 2 other identifiers: 16297I8K-MC-JPDE
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure how much LY3337641 gets into the bloodstream and how long it takes the body to get rid of it. In addition, the safety and tolerability of the study drug will be evaluated. Participants will be admitted to a clinical research unit (CRU) the day before dosing. Participants remain confined to the CRU for at least 7 days. Participants may be discharged from the CRU any time after 7 days post-dose (Day 8), and up to a maximum of 21 days post-dose (Day 22). This study will last approximately 30 days for each participant, not including screening. Screening is required within 28 days prior to the start of the study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Urinary excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in urine samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in urine and feces.

  Baseline up to 22 days

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

  Fecal excretion samples from each participant were measured by liquid scintillation counting. The radioactive counts detected in fecal samples were each divided by the theoretical radioactive count in the total radioactive dose administered and multiplied by 100% to arrive at a percentage of total radioactive dose excreted in feces.

  Baseline up to 22 days

Secondary Outcomes (7)

• Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma LY3337641

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

• Pharmacokinetics: Maximum Observed Concentration (Cmax) of Plasma Radioactivity

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

• Pharmacokinetics: Maximum Observed Concentration (Cmax) of Whole Blood Radioactivity

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

• Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma LY3337641

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

• Pharmacokinetics: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC 0 to ∞) of Plasma Radioactivity

  Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 216, 264 and 312 hours post dose

Study Arms (1)

20mg [¹⁴C]-LY3337641

EXPERIMENTAL

Participants received 20 milligrams (mg) oral dose of LY3337641 containing 120 microcuries of radioactivity.

Drug: [¹⁴C]-LY3337641

Interventions

[¹⁴C]-LY3337641 DRUG

Administered orally

20mg [¹⁴C]-LY3337641

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy males, as determined by medical history and physical examination
• Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²)
• Have clinical laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
• Have venous access sufficient to allow for blood sampling as per the protocol
• Are able and willing to give signed informed consent
• Generally have a minimum of 1 bowel movement per day

You may not qualify if:

• Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer, if known) should have passed
• Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI) (cholecystectomy not acceptable), endocrine, hematological, dermatologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Have used or intend to use over-the-counter or prescription medication, including herbal medications, within 14 days prior to dosing
• Have donated blood of more than 500 milliliter (mL) within the month prior to screening
• Have an average weekly alcohol intake that exceeds 21 units per week, and are unwilling to stop alcohol consumption for 48 hours prior to admission, and while resident in the clinical research unit (CRU)
• Have had exposure to significant diagnostic, therapeutic, or employment related radiation within 12 months prior to dosing (serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
• Have participated in a \[¹⁴C\] study within the last 6 months prior to admission for this study. The total 12-month exposure from this study and a maximum of one other previous \[¹⁴C\]-study within 6 to 12 months of this study must be within the Code of Federal Regulations (CFR) recommended levels considered safe (per 21 CFR 361.1): less than 5000 Milli-rem (mrem) /year whole body annual exposure

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: September 26, 2016
• Study Start: September 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 25, 2023
• Results First Posted: August 25, 2023

Record last verified: 2022-10

Locations

US (1)