A Study of LY2157299 Monohydrate in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01746004
First received: December 6, 2012
Last updated: February 14, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: [^14C]-LY2157299
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Disposition of [14C]-LY2157299 Monohydrate Following Oral Administration in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Urinary and Fecal Excretion of LY2157299 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered [ Time Frame: Pre-dose through Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax) [ Time Frame: Pre-dose through Day 14 ] [ Designated as safety issue: No ]
  • Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax) [ Time Frame: Pre-dose through Day 14 ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: Pre-dose through Day 14 ] [ Designated as safety issue: No ]
  • Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces [ Time Frame: Pre-dose through Day 14 ] [ Designated as safety issue: No ]
  • Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma [ Time Frame: Pre-dose through Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 8
Study Start Date: January 2013
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746004

Locations
United States, Wisconsin
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01746004     History of Changes
Other Study ID Numbers: 14671, H9H-MC-JBAM
Study First Received: December 6, 2012
Last Updated: February 14, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014