A Study of [¹⁴C]-LY3202626 in Healthy Male Participants

NCT02555449 | Completed Phase 1 Results

• 2 other identifiers: 15566I7X-EW-LLCC
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to measure how much of the specially prepared study drug, LY3202626, containing radiolabeled carbon \[¹⁴C\] gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. Participants will stay at a clinical research unit (CRU). The study will last about 28 days (check in to follow-up) for each participant. This study is for research purposes only and is not intended to treat any medical condition.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

  Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.

  Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met

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

  Urinary excretion of radioactivity over time was expressed as a percentage of the total radioactive dose administered

  Predose, 6, 12, 24, 48, 72 Hours At 24 Hour Intervals Until Release Criteria Met

Secondary Outcomes (5)

• Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)

  Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met

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

  Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met

• Plasma Radioactivity Pharmacokinetics Area Under the Concentration-time Curve From Time Zero to the Last Timepoint With a Measurable Concentration (AUC[0-tlast])

  Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168 Hours At 24 Hour Intervals Until Release Criteria Met

• Total Number of Metabolites Representing at Least 10% of the Total Radioactivity in Plasma

  Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24 Hours Postdose

• Total Number of Metabolites in Excreta (Urine and Feces) That Represent at Least 10% of the Dose of Radioactivity

  From Dosing Until Release Criteria Is Met

Study Arms (1)

[¹⁴C]-LY3202626

EXPERIMENTAL

Single oral dose of LY3202626 containing 100 micro curies of radioactivity

Drug: [¹⁴C]-LY3202626

Interventions

[¹⁴C]-LY3202626 DRUG

Administered as solution by mouth

[¹⁴C]-LY3202626

Eligibility Criteria

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

You may qualify if:

• Are overtly healthy males, as determined by physical examination, clinical laboratory tests, medical history and electrocardiogram (ECG)
• Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive at screening

You may not qualify if:

• Have participated in a \[¹⁴C\]-study within the last 6 months prior to admission for this study
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange-containing products, star fruits or star fruit-containing products within 7 days prior to dosing or intend to consume during the study
• Have a history of constipation or have had acute constipation within 3 weeks prior to admission
• Are currently or have been smokers or users of tobacco or nicotine replacement products within the 3 months prior to admission and/or have positive cotinine at screening or check-in
• 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)

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Unit Inc.

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 17, 2015
• First Posted: September 21, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 19, 2021
• Results First Posted: April 19, 2021

Record last verified: 2021-03

Locations

US (1)