A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Atorvastatin; Drug: Evacetrapib; Drug: Simvastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02156492

14467

I1V-MC-EIAM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 6 patient groups

Evacetrapib Single

Experimental group

Description:

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

Treatment:

Drug: Evacetrapib

Evacetrapib Multiple

Experimental group

Description:

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

Treatment:

Drug: Evacetrapib

Simvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Simvastatin

Evacetrapib and Simvastatin

Experimental group

Description:

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

Treatment:

Drug: Simvastatin

Drug: Evacetrapib

Atorvastatin

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin

Evacetrapib and Atorvastatin

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin

Drug: Evacetrapib