A Study of LY2157299 Monohydrate in Healthy Volunteers

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01746004
Collaborator
(none)
8
1
1
1
7.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Disposition of [14C]-LY2157299 Monohydrate Following Oral Administration in Healthy Subjects
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Feb 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax) [Pre-dose through Day 14]

  2. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax) [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) [Pre-dose through Day 14]

  4. Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces [Pre-dose through Day 14]

  5. Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma [Pre-dose through Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
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 53704

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01746004
Other Study ID Numbers:
  • 14671
  • H9H-MC-JBAM
First Posted:
Dec 10, 2012
Last Update Posted:
Feb 15, 2013
Last Verified:
Feb 1, 2013

Study Results

No Results Posted as of Feb 15, 2013