Clinical trial NCT02156492: A Study of Evacetrapib With Selected Statins in Healthy Chinese Participants
Official title: A Pharmacokinetic, Pharmacodynamic, and Drug-Drug Interaction Study of Evacetrapib With Selected Statins in Healthy Chinese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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* Have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the IP within 3 months.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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under Curve (AUC 0-inf) of Evacetrapib
timeFrame: Part 1: Day 1 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours Postdose
measure: PK: Maximum Concentration (Cmax) of Evacetrapib
timeFrame: Part 1: Day 1 and Day 14 Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours Postdose; Part 2 Day 14: Predose 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours Postdose
measure: PK: Time to Maximum Concentration (Tmax) of Evacetrapib
timeFrame: Part 1: Day 1 Predose on Day 1 or Day 14 and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 144, and 168 hours postdose. Part 2: Predose on Day 14 at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post dose.
measure: PK: AUC of Evacetrapib Alone and With Simvastatin or Atorvastatin
timeFrame: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose
measure: PK: Cmax of Evacetrapib Alone and With Simvastatin or Atorvastatin
timeFrame: Part 2: Day 14 and 22 Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours Postdose.
measure: PK: Tmax of Evacetrapib Alone and With Simvastatin or Atorvastatin
timeFrame: Part 2: Predose on Day 14 and 22 and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours postdose.
Secondary outcomes:
measure: Effect of Evacetrapib Single and Multiple Doses on High Density Lipoprotein Cholesterol (HDL-C), Low Density Lipoprotein Cholesterol (LDL-C), and Triglycerides (TG)
timeFrame: Single Dose Day 2 and Multiple Dose Day 22
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: