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OpenTrials
Completed

NCT Number: NCT04033341

A Study of LY3214996 in Healthy Participants

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will involve a single dose of 14C radiolabelled LY3214996. This means that a radioactive substance, C14, will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to six weeks.

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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 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

  • Overtly health males
  • Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive

Exclusion criteria

  • Females
  • Male participants sexually active with a pregnant partner
  • Are currently enrolled in a clinical study or have participated, within the last 30 days, in a clinical study
  • Have participated in a radiolabeled drug study within the previous 4 months
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
  • Have a history of Gilbert's syndrome
  • Have history or presence of psychiatric disorders
  • Show evidence of human immunodeficiency virus (HIV) infection
  • Show evidence of hepatitis C
  • Show evidence of hepatitis B

Treatment and study plan

LY3214996

Drug

Administered orally

[14C]-LY3214996

Drug

Administered orally

Primary outcomes

  1. Urinary Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

    Time frame: Baseline through Day 8 after administration of study drug

    Urinary Excretion of LY3214996 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

  2. Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

    Time frame: Baseline through Day 8 after administration of study drug

    Fecal Excretion of LY3214996 Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3214996

    Time frame: Predose through Day 8 after administration of study drug

    PK: Cmax of LY3214996

  2. PK: Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3214996

    Time frame: Predose through Day 8 after administration of study drug

    PK: AUC(0-∞) of LY3214996

  3. Total Number of Metabolites of LY3214996

    Time frame: Baseline through 48 hours after administration of study drug

    Total Number of Metabolites of LY3214996

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Disposition of [14C]-LY3214996 Following Oral Administration in Healthy Male Subjects

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2019
Registry last updated
Oct 29, 2019

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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