A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants

NCT ID: NCT02156492

Last Updated: 2018-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2014-12-31

Brief Summary

The main purpose of this study is to investigate how the body responds to evacetrapib and to evaluate the safety and the effect of evacetrapib, alone and in combination with selected statins, in healthy Chinese participants. The study has 2 parts. Part one will last up to 4 weeks and part two will last up to 5 weeks, not including screening. Participants may only enroll in one part.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Evacetrapib Single

Part 1, Cohort A, Period 1, Participants will receive a single oral 130 mg dose of evacetrapib.

Group Type: EXPERIMENTAL

Evacetrapib

Intervention Type: DRUG

Administered orally.

Evacetrapib Multiple

Part 1, Cohort A, Period 2, Participants will receive multiple doses of evacetrapib for 14 days.

Group Type: EXPERIMENTAL

Evacetrapib

Intervention Type: DRUG

Administered orally.

Simvastatin

Part 2, Cohorts B, Participants will receive simvastatin orally, once daily on Days 1 - 4.

Group Type: ACTIVE_COMPARATOR

Simvastatin

Intervention Type: DRUG

Administered orally.

Evacetrapib and Simvastatin

Part 2, Cohorts B, Participants will receive evacetrapib orally once daily on Days 5 - 14 and simvastatin orally, once daily on Days 15 - 22.

Group Type: EXPERIMENTAL

Evacetrapib

Intervention Type: DRUG

Administered orally.

Simvastatin

Intervention Type: DRUG

Administered orally.

Atorvastatin

Part 2, Cohorts C, Participants will receive atorvastatin orally, once daily on Days 1 - 4.

Group Type: ACTIVE_COMPARATOR

Atorvastatin

Intervention Type: DRUG

Administered orally.

Evacetrapib and Atorvastatin

Part 2, Cohorts C, Participants will receive evacetrapib orally once daily on Days 5 - 14 and atorvastatin orally, once daily on Days 15 - 22.

Group Type: EXPERIMENTAL

Evacetrapib

Intervention Type: DRUG

Administered orally.

Atorvastatin

Intervention Type: DRUG

Administered orally.

Interventions

Evacetrapib

Administered orally.

Intervention Type: DRUG

Simvastatin

Administered orally.

Intervention Type: DRUG

Atorvastatin

Administered orally.

Intervention Type: DRUG

Other Intervention Names

LY2484595

Eligibility Criteria

Inclusion Criteria

• Are native Chinese and living in China.
• Are overtly healthy males or females as determined by medical history and physical examination.
• Female participants:

• Women not of child-bearing potential
• Women of child-bearing potential must correctly use 2 forms of reliable contraception to avoid getting pregnant during the study and for 3 months after the study is completed.
• Body Mass Index: 19.0 to 24.0 kilogram per square meter (kg/m^2)
• BP and pulse rate at both supine and standing positions of approximately a systolic BP ≤ 140 millimeter of mercury (mm Hg), and diastolic BP ≤ 90 mm Hg
• Participants with untreated hypercholesterolemia may be included if not on an herbal or other traditional Chinese medicines (TCM)
• Have no known liver disease
• Have given written informed consent

Exclusion Criteria

• Are currently enrolled in a clinical trial involving an investigational product (IP) 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 evacetrapib, simvastatin, or atorvastatin, related compounds or any components of the formulation
• Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.
• Have a history within the last year 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
• Are women with a positive pregnancy test or women who are lactating.
• Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements) or TCM 14 days prior to the first dose and during the study.

• Hormonal contraceptives are permitted.
• Use of any drugs or substances that are known to be substrates, inducers, or inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1), or of any other transporters involved in simvastatin or atorvastatin disposition, or of any drugs or substances that are known to be strong inducers or inhibitors of cytochrome P450 3A (CYP3A) within 30 days prior to the first dose and throughout the study.
• Donated blood of >400 mL within the last month.
• Drink alcoholic beverages with intake that exceeds 28 units per week (males) and 21 units per week (females), or are unwilling to stop alcohol consumption 48 hours prior to dosing until discharge from 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).
• Are unwilling to comply with the dietary requirements/restrictions during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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.

Beijing, , China

Countries

China

Other Identifiers

I1V-MC-EIAM

Identifier Type: OTHER

Identifier Source: secondary_id

14467

Identifier Type: -

Identifier Source: org_study_id