A Study of LY2157299 Monohydrate in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [^14C]-LY2157299

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [^14C]-LY2157299; Single 150 mg oral dose of LY2157299 monohydrate containing 100 micro curies of [^14C] labeled drug	Drug: [^14C]-LY2157299; [^14C]-LY2157299 monohydrate administered as oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered	Pre-dose through Day 15

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)	Pre-dose through Day 14
Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)	Pre-dose through Day 14
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)	Pre-dose through Day 14
Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces	Pre-dose through Day 14
Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma	Pre-dose through Day 14

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 6, 2012
• First Posted (Estimate): December 10, 2012

Study Record Updates

• Last Update Posted (Estimate): February 15, 2013
• Last Update Submitted That Met QC Criteria: February 14, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 14671; H9H-MC-JBAM (Other Identifier: Eli Lilly and Company)