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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: [¹⁴C]-LY3202626

• Registration Number: NCT02555449
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-21
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2021-03
• Results First Submitted: 2021-03-22
• Results First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Results First Posted: 2021-04-19
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[¹⁴C]-LY3202626	[¹⁴C]-LY3202626	Single oral dose of LY3202626 containing 100 micro curies of radioactivity

Primary Outcome Measures

Name	Time	Method
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	Fecal excretion of radioactivity over time expressed as a percentage of the total radioactive dose administered.
Urinary 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 was expressed as a percentage of the total radioactive dose administered

Secondary Outcome Measures

Name	Time	Method
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	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\[0-tlast\]).
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 were measured by the maximum observed concentration (Cmax).
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 were measured by the area under the concentration-time curve from time zero to infinity (AUC\[0-∞\]).
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 were identified in at least 10% of the total radioactivity in plasma.
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	The total number of metabolites identified in excreta (urine and feces) that represent at least 10% of the dose of radioactivity

Trial Locations

Locations (1)

Covance Clinical Research Unit Inc.; 🇺🇸 Madison, Wisconsin, United States