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OpenTrials
Completed

NCT Number: NCT01981408

A Study of LY2801653 in Healthy Participants

This type of study is called a radiolabeled study. For this study, LY2801653 (study drug) has been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy people. Information about any side effects that may occur will also be collected. This study will last up to 15 days for each participant, not including screening. Screening is required within 28 days prior to enrollment.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madison, Wisconsin, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Generally healthy sterile male and female participants
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2), inclusive

Exclusion criteria

  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Have consumed herbal supplements, grapefruit juice, grapefruits, grapefruit containing products, Seville orange juice, Seville oranges, star fruit, or star fruit juice within 7 days prior to dosing or intend to consume during the study
  • Have donated blood of more than 500 milliliter (mL) within the last month
  • Have participated in a [14C]-study within the last 6 months prior to admission for this study
  • Exposure to significant radiation within 12 months prior to dose (for example, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
  • Have a defecation pattern less than once per 2 days or acute constipation within 3 weeks of day before dosing

Treatment and study plan

[^14C]-LY2801653

Drug

Administered orally

Primary outcomes

  1. Urinary and Fecal Excretion of LY2801653 Radioactivity over Time expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Pre-dose up to 14 days post dose

Secondary outcomes

  1. Plasma Pharmacokinetics of LY2801653 and Radioactivity Maximum Observed Concentration (Cmax)

    Time frame: Pre-dose up to 14 days post dose

  2. Plasma Pharmacokinetics of LY2801653 and Radioactivity Time of Maximum Concentration (tmax)

    Time frame: Pre-dose up to 14 days post dose

  3. Plasma Pharmacokinetics of LY2801653 and Radioactivity Area Under The Concentration-time Curve from zero to the last timepoint with a measurable Concentration (AUC 0 to tlast)

    Time frame: Pre-dose up to 14 days post dose

  4. Relative Abundance of LY2801653 and the Metabolites of LY2801653 in Urine and Feces

    Time frame: Pre-dose up to 14 days post dose

  5. Relative Abundance of LY2801653 and the Metabolites of LY2801653 in Plasma

    Time frame: Pre-dose up to 14 days post dose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Disposition of [^14C]-LY2801653 Following Oral Administration in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2013
Registry last updated
Jan 9, 2014

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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