A Study of LY2157299 in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01965808
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
2
Duration (Months)
8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken at least 4 days apart. One dose will be given without food. One dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 15 days not including screening. Screening is required within 30 days prior to the start of the study.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Effect of Food on the Pharmacokinetics of LY2157299 Monohydrate in Healthy Subjects
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

ArmIntervention/Treatment
Experimental: LY2157299 (Fasted)

Single dose of 150 mg LY2157299 administered orally in fasted state in one of two study periods.

Drug: LY2157299
Administered orally

Experimental: LY2157299 (Fed)

Single dose of 150 mg LY2157299 administered orally in fed state in one of two study periods.

Drug: LY2157299
Administered orally

Outcome Measures

Primary Outcome Measures

  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299 [Pre-dose through 72 hours post-dose in each study period]

  2. Pharmacokinetics: Time of Maximum Observed Concentration (tmax) of LY2157299 [Pre-dose through 72 hours post-dose in each study period]

  3. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2157299 [Pre-dose through 72 hours post-dose in each study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy sterile males or females

  • Are able to eat a high fat meal

  • No abnormal heart function or high blood pressure

  • No participation in a clinical trial within 30 days

  • No evidence of human deficiency virus (HIV), hepatitis C or hepatitis B

Exclusion Criteria:
  • Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1For 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.Daytona BeachFloridaUnited States31227

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:
NCT01965808
Other Study ID Numbers:
  • 15239
  • H9H-MC-JBAU
First Posted:
Oct 18, 2013
Last Update Posted:
Dec 4, 2013
Last Verified:
Dec 1, 2013

Study Results

No Results Posted as of Dec 4, 2013