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A Study of LY2157299 Monohydrate in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01746004
Recruitment Status : Completed
First Posted : December 10, 2012
Last Update Posted : February 15, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: [^14C]-LY2157299 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
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 : January 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Maximum Observed Concentration (Cmax) [ Time Frame: Pre-dose through Day 14 ]
  2. Plasma Pharmacokinetics (PK) of LY2157299 and Radioactivity Time of Maximum Observed Concentration (Tmax) [ Time Frame: 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) [ Time Frame: Pre-dose through Day 14 ]
  4. Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Urine and Feces [ Time Frame: Pre-dose through Day 14 ]
  5. Relative Abundance of LY2157299 and the Metabolites of LY2157299 in Plasma [ Time Frame: Pre-dose through Day 14 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01746004     History of Changes
Other Study ID Numbers: 14671
H9H-MC-JBAM ( Other Identifier: Eli Lilly and Company )
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013