A Study of LY2157299 Monohydrate in Healthy Volunteers

NCT01746004 | Completed Phase 1

• 2 other identifiers: 14671H9H-MC-JBAM
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

[^14C]-LY2157299

EXPERIMENTAL

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

Drug: [^14C]-LY2157299

Interventions

[^14C]-LY2157299 DRUG

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

[^14C]-LY2157299

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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, 53704, United States

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

US (1)