A Study of LY2484595 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01450098
First received: October 7, 2011
Last updated: January 12, 2012
Last verified: January 2012
  Purpose

The purpose of this study will be to evaluate the safety of a single dose of LY2484595 and to compare the amount of LY2484595 in the blood of healthy non-Asian subjects, Chinese subjects and first generation Japanese subjects after receiving a single oral dose of LY2484595 in a fasted state, after eating a low-fat meal and after eating a high-fat meal.


Condition Intervention Phase
Healthy Volunteers
Drug: LY2484595 Reference Formulation (RF)
Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Single Dose LY2484595 Tablet Formulations to Determine the Impact of Dose Level, Food, and Ethnicity on the Pharmacokinetics in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Pharmacokinetics: Area under the plasma concentration versus time curve (AUC) of LY2484595 [ Time Frame: Pre-dose up to 168 hours post-dose for each treatment period ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595 [ Time Frame: Pre-dose up to 168 hours post-dose for each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with one or more drug related Adverse Events (AEs) or any Serious AEs [ Time Frame: Baseline to completion of study (approximately 2 months) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort A: fixed sequence of meal conditions
200 mg of LY2484595 administered orally, one time only, as a spray-dried solid dispersion-propyl gallate (SDSD-PG) tablet given with no food. There will be a washout of a minimum of 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with low fat breakfast. There will be another washout of a minimum of 14 days before crossing over and receiving a 200 mg of LY2484595 administered orally, one time only, as a SDSD-PG tablet given with high fat breakfast.
Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
Administered orally
Experimental: Cohort B: Comparison of randomized treatments
100 mg of LY2484595 administered orally as reference formulation (RF) tablet given with a low fat breakfast. There will be a washout of a minimum of 14 days before crossing over and receiving 100 mg of LY2484595 administered orally as a SDSD-PG tablet given with a low fat breakfast. There will be another washout of a minimum of 14 days before crossing over and receiving 300 mg of LY2484595 as a SDSD-PG tablet given with a low fat breakfast.
Drug: LY2484595 Reference Formulation (RF)
Administered orally
Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)
Administered orally

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination. For Cohort B, a first-generation Japanese subject is defined as one who is Japanese and was born in Japan and whose parents and all grandparents are Japanese and were born in Japan. A first-generation Chinese subject is defined as one who is Chinese and was born in China (mainland or Taiwan) and whose parents and all grandparents are Chinese and were born in China
  • Female subjects are not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are at least age 45, have had cessation of menses for at least 1 year, and have not taken hormones or oral contraceptives (including estrogen or hormone replacement therapy) during the past 12 months
  • Are between the body mass index (BMI) of 18.5 and 29.0 kg/m^2, inclusive
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
  • Acceptable blood pressure (BP) and heart rate at both supine and standing positions as determined by the investigator (systolic BP less than or equal to 140 mm Hg, and diastolic BP less than or equal to 90 mm Hg). A single repeat BP measurement may be done at the discretion of the investigator
  • Have venous access sufficient to allow blood sampling
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
  • Have given written informed consent approved by Eli Lilly and Company (hereafter, Lilly) and the ethical review board (ERB) governing the site

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device, or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have known allergies to LY2484595 or related compounds
  • Are persons who have previously completed or withdrawn from this study
  • Have an abnormality in the 12-lead electrocardiogram (ECG) (including but not limited to a Bazett's corrected QT [QTcB] interval >450 msec for men and >470 msec for women) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have a history within the last 2 years or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurologic disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
  • Show evidence of significant active neuropsychiatric disease
  • Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
  • Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies
  • Show evidence of hepatitis C and/or positive hepatitis C antibody
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen
  • Are women with a positive pregnancy test or women who are lactating
  • Intend to use and actually use over-the-counter or prescription medication or dietary supplements within 14 days prior to dosing (acetaminophen is permissible on an as-needed basis, at less than 3 grams per day for less than 7 days)
  • Have donated blood of more than 500 mL within the last month
  • Have an average alcohol intake that exceeds 14 units per week, or are unwilling to stop alcohol consumption for 48 hours prior and during the inpatient confinement at the Clinical Research Unit (CRU) (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
  • Use herbal supplements, grapefruit juice, grapefruits, Seville orange juice, Seville oranges, or starfruit within 7 days prior to study dosing
  • Smoke more than 10 cigarettes per day currently and are unwilling to abide by the CRU guidelines
  • Are unwilling to refrain from daily consumption of real licorice
  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: NCT01450098

Locations
United States, California
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.
Glendale, California, United States, 91206
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: NCT01450098     History of Changes
Other Study ID Numbers: 13697, I1V-MC-EIAJ
Study First Received: October 7, 2011
Last Updated: January 12, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Propyl Gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014