A Study of LY2157299 Monohydrate in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01746004
• Other study ID #: 14671
• Secondary ID: H9H-MC-JBAM
• Status: Completed
• Phase: Phase 1
• First received: December 6, 2012
• Last updated: February 14, 2013
• Start date: January 2013
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered		Pre-dose through Day 15	No
Secondary	Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax)		Pre-dose through Day 14	No
Secondary	Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax)		Pre-dose through Day 14	No
Secondary	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	No
Secondary	Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces		Pre-dose through Day 14	No
Secondary	Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma		Pre-dose through Day 14	No