A Study of LY2157299 Monohydrate in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [^14C]-LY2157299

• Registration Number: NCT01746004
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-06
• Study First Posted: 2012-12-10
• Study Start: 2013-01
• Status Verified: 2013-02
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[^14C]-LY2157299	[^14C]-LY2157299	Single 150 mg oral dose of LY2157299 monohydrate containing 100 micro curies of \[\^14C\] labeled drug

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

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