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

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: [¹⁴C]-LY3202626

Study type

Interventional

Funder types

Industry

Identifiers

NCT02555449
15566
I7X-EW-LLCC (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

[¹⁴C]-LY3202626
Experimental group
Description:
Single oral dose of LY3202626 containing 100 micro curies of radioactivity
Treatment:
Drug: [¹⁴C]-LY3202626

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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