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Completed

NCT Number: NCT01746004

A Study of LY2157299 Monohydrate in Healthy Volunteers

This study involves a single dose of 150 milligram (mg) of radiolabeled LY2157299 monohydrate in healthy participants. The study will determine how the body eliminates the radioactivity and LY2157299 monohydrate. Participants must be healthy surgically sterile or postmenopausal females, or sterile males. This study is approximately 8 to 15 days.

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Key information

Conditions

Healthy Volunteers

Age range

21 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, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy surgically sterile females, postmenopausal females, or sterile males
  • Body mass index (BMI) of 18.5 to 32.0 kilograms per square meter (kg/m^2)
  • Have venous access sufficient to allow for blood sampling

Exclusion criteria

  • Have known allergies to LY2157299, related compounds or any components of the formulation
  • Have an abnormal blood pressure as determined by the investigator
  • Have participated in a [^14C]-study within the last 6 months prior to admission for this study

Treatment and study plan

[^14C]-LY2157299

Drug

[^14C]-LY2157299 monohydrate administered as oral solution

Primary outcomes

  1. Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

    Time frame: Pre-dose through Day 15

Secondary outcomes

  1. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)

    Time frame: Pre-dose through Day 14

  2. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)

    Time frame: Pre-dose through Day 14

  3. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Area Under the Concentration-Time Curve from Time Zero to the Last Timepoint with a Measurable Concentration (AUC 0 to tlast)

    Time frame: Pre-dose through Day 14

  4. Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces

    Time frame: Pre-dose through Day 14

  5. Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma

    Time frame: Pre-dose through Day 14

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Disposition of [14C]-LY2157299 Monohydrate Following Oral Administration in Healthy Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 10, 2012
Registry last updated
Feb 15, 2013

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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