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Completed

NCT Number: NCT02555449

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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

[¹⁴C]-LY3202626

Drug

Administered as solution by mouth

Primary outcomes

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

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

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

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

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

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

Secondary outcomes

  1. Plasma Radioactivity Pharmacokinetics Maximum Observed Concentration (Cmax)

    Time frame: 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 were measured by the maximum observed concentration (Cmax).

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

    Time frame: 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 were measured by the area under the concentration-time curve from time zero to infinity (AUC[0-∞]).

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

    Time frame: 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 were measured by the area under the concentration-time curve from time zero to the last timepoint with a measurable concentration (AUC[0-tlast]).

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

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

    Total number of metabolites were identified in at least 10% of the total radioactivity in plasma.

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

    Time frame: From Dosing Until Release Criteria Is Met

    The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Disposition of [¹⁴C]-LY3202626 Following Oral Administration in Healthy Male Subjects

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2015
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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