A study of Evacetrapib and Pravastatin in healthy Japanese and Non-Japanese participants
- Conditions
- Healthy Volunteers (High risk vascular disease)MedDRA version: 14.1Level: LLTClassification code 10067825Term: Peripheral arterial diseaseSystem Organ Class: 100000004866MedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: PTClassification code 10011078Term: Coronary artery diseaseSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: LLTClassification code 10003602Term: Atherosclerosis cerebralSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-002935-12-GB
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
All subjects must meet the following criteria for enrollment (inclusion criteria [1] through [7]). Inclusion criterion [8] is specific to protocol-defined Japanese subjects. Subjects are eligible for enrollment in the study only if they meet all of the following criteria:
[1] are overtly healthy individuals, as determined by medical history and physical examination.
[1a] male subjects: agree to use 2 acceptable methods of birth control (as deemed by the investigator) and not donate sperm during the study and for 90 days following the last dose of the investigational product
[1b] female subjects: are women of child-bearing potential who test negative for pregnancy at the time of screening based on a serum pregnancy test and agree to use 2 acceptable methods of birth control from the Screening Visit until 90 days after the last dose of the investigational product
or
are women who have undergone bilateral tubal ligation who test negative for pregnancy at the time of screening based on a serum pregnancy test and agree to use 1 additional acceptable method of birth control from the Screening Visit until 90 days after the last dose of the investigational product,
or
are post-menopausal women or women not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical hysterectomy, bilateral oophorectomy, or tubal occlusion) confirmed by medical history,
or
menopause post-menopausal women include women with spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy) and a follicle-stimulating hormone level greater than 40 mIU/mL
[2] are at least 18 (for Japanese, 20) to 65 years old, inclusive, at the time of screening
[3] have a body mass index (BMI) of 18 to 32 kg/m2, inclusive, at the time of screening
[4] 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
[5] have venous access sufficient to allow for blood sampling as per the protocol
[6] are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
[7] have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study Japanese Subjects
[8] are 1st generation Japanese, defined as the subject, the subject’s biological parents, and all of the subject’s biological grandparents must be of exclusive Japanese descent and have been born in Japan
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
Subjects will be excluded from study enrollment if they meet any of the following criteria:
[9] are investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
[10] are Lilly employees
[11] are currently enrolled in a clinical trial involving an investigational product 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
[12] are persons who have previously completed or withdrawn from this study or any other study investigating evacetrapib, and have previously received the investigational product within 3 months. This exclusion does not apply to subjects who are allowed to re-screen prior to randomization.
[13] have known allergies to evacetrapib or pravastatin, related compounds or any components of the formulation, or history of significant allergic disease as determined by the investigator
[14] have an abnormality in the 12-lead ECG that, in the opinion of the
investigator, increases the risks associated with participating in the study
[15] have an abnormal blood pressure as determined by the investigator
[16] have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological 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
[17] regularly use known drugs of abuse and/or show positive findings on urinary drug screening
[18] show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
[19] show evidence of hepatitis C and/or positive hepatitis C antibody
[20] show evidence of hepatitis B and/or positive hepatitis B surface antigen
[21] are women who are pregnant or who are lactating
[22] have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements/herbal medicine) 14 days prior to the first dose and during the study. The use of topical medicine, provided there is no evidence of chronic dosing with risk of systemic exposure, and occasional acetaminophen is acceptable. The use of hormonal contraceptives is permitted. Refer to Section 9.6 for concomitant medication restrictions.
[23] use of any drugs or substances that are known to be substrates, inducers, or inhibitors of OATP1B1 or of any other transporters involved in pravastatin disposition, or of any drugs or substances that are known to be strong inducers or inhibitors of CYP3A within 30 days prior to the first dose and throughout the study
[24] have donated blood of more than 500 mL within the last 3 months
[25] have an average weekly alcohol 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 CRU following Period 2 (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)
[26] are subjects who currently smoke more than 10 cigarettes per day (or equivalent in tobacco or nicotine products) or are unwilling to abide by the CRU guidelines on smoking while resident
[27] history of, in the opinion of the investigator, excessive methylxanthine
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine the effect of 130 mg evacetrapib on the pharmacokinetics (PK)<br>of pravastatin in healthy Japanese and non-Japanese subjects.;Secondary Objective: The secondary objective is to assess the tolerability of evacetrapib when coadministered with pravastatin in healthy<br>Japanese and non-Japanese subjects.;Primary end point(s): Maximum observed concentration (Cmax), area under the concentration versus time curve (AUC) from zero to infinity (AUC([0-8]), and time of maximum observed concentration (tmax) following both doses.;Timepoint(s) of evaluation of this end point: Day 1 and Day 11, predose of pravastatin through 24 hours post dose
- Secondary Outcome Measures
Name Time Method Secondary end point(s): All investigational product and protocol procedure AEs will be listed, and if the frequency of events allows, safety data will be summarised using descriptive methodology.;Timepoint(s) of evaluation of this end point: Day -1 through Follow Up Visit