A Study of LY2484595 in Healthy Subjects

NCT01450098 | Completed Phase 1 Results

• 2 other identifiers: 13697I1V-MC-EIAJ
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of LY2484595

  Area under the concentration-time curve from time zero to infinity is presented.

  Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose

• Pharmacokinetics: Peak Plasma Concentration (Cmax) of LY2484595

  Predose and 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, and 168 hours postdose

Secondary Outcomes (1)

• Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs

  Baseline through completion of study (approximately 2 months)

Study Arms (2)

Cohort A: Fixed Sequence of Meal Conditions

EXPERIMENTAL

LY2484595 (evacetrapib): 200 milligrams (mg) of LY2484595 administered orally, one time only, as an SDSD-PG tablet given with no food. There was a washout of at least 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 was another washout period of at least 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)

Cohort B: Comparison of Randomized Treatments

EXPERIMENTAL

LY2484595 (evacetrapib): 100 mg of LY2484595 administered orally as an RF tablet given with a low-fat breakfast. There was a washout period of at least 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 was another washout of at least 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); Drug: LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)

Interventions

LY2484595 Reference Formulation (RF) DRUG

Administered orally

Also known as: Evacetrapib

Cohort B: Comparison of Randomized Treatments

LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG) DRUG

Administered orally

Also known as: Evacetrapib

Cohort A: Fixed Sequence of Meal Conditions; Cohort B: Comparison of Randomized Treatments

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Have a body mass index (BMI) of 18.5 to 29.0 kilograms per meter squared (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
• Have an 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 millimeters of mercury \[mmHg\], and diastolic BP less than or equal to 90 mmHg). 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

You may not qualify if:

• 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 milliseconds (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 milliliters (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 ounces \[oz\] 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (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.

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

evacetrapib

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 12, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 3, 2018
• Results First Posted: October 3, 2018

Record last verified: 2018-02

Locations

US (1)