Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy males, as determined by medical history and physical examination, must agree to use a medically appropriate method of birth control and agree not to donate sperm from start of dosing until 90 days beyond last dose
Healthy females, as determined by medical history and physical examination, of non-child bearing potential due to:
* Menopause: spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications that induced the amenorrhea (for example: oral contraceptives, hormones, gonadotropin releasing hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy)
* Surgical sterilization
Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
Have a Body Mass Index (BMI) 18 to 30 kilogram per square meter (kg/m²) at entry
Have clinical laboratory test results within normal reference range for the population or site, or results with acceptable deviations that are judged not clinically significant
Be 18 to 55 years old for either Part A or Part B of the study, or 18 to 65 years old for Part C only
For Part C: must have been treated with a stable dose of ACE-I or ARB for at least 1 month
You may not be if
Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval
Have previously completed or withdrawn from this study or any other study investigating this study drug
Have a history or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, significant atopy, or any clinically significant laboratory abnormality that would preclude study participation
Have abnormality in the 12-lead electrocardiogram (ECG) which increases study risk
Have confirmed QT interval corrected by Bazett's method (QTcB) or Fridericia's (QTcF) method \>450 millisecond (msec) for men and \>470 msec for women
Have prior Q-wave myocardial infarction or other, specific heart abnormalities, arrhythmias or fibrillations
Have an abnormal blood pressure (supine) defined as diastolic blood pressure greater than (\>)95 or less than (\<)50 millimeters of mercury (mmHg) and/or systolic blood pressure \>160 or \<90 mmHg
Show evidence of human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
Have donated blood of more than 100 mL (milliliters) within the last month
Are unwilling to stop alcohol consumption while resident in the Clinical Research Unit
Have an average weekly alcohol intake that exceeds 21 units per week (1 unit equal to (=) 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
Have an abnormal blood pressure (supine) defined as diastolic blood pressure \>95 or \<50 mmHg and/or systolic blood pressure \>160 or \<90 mmHg
Have serum potassium outside normal range
Have had lymphoma, leukemia, or any malignancy within the past 5 years
Have clinically significant multiple or severe drug allergies or intolerance
Are lactating women
Positive findings for known drugs of abuse
Have received treatment with biologic agents within 3 months or 5 half-lives prior to dosing
Participation in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be compatible with this study
Have estimated glomerular filtration rate (eGFR) \< 60 milliliters per minute per 1.73 square meter (mL/min/1.73 m²) for Parts A and B of this study, or eGFR \< 50 mL/min/1.73 m² in Part C only
For Part C: have a history of severe hypertension (defined as SBP greater than or equal to (≥)180 mmHg and/or DBP ≥120 mmHg), secondary hypertension, symptomatic postural hypotension, or hospitalization due to hypertension
For Part C: have a history of supraventricular tachycardia (for example, atrial fibrillation), ventricular tachycardia, or other cardiac arrhythmia
For Part C: have resting tachycardia (heart rate ≥100 beats per minute)
For Part C: have New York Heart Association (NYHA) Class II, III, or IV heart failure, or had any of the following in the previous 3 months: coronary angioplasty, coronary stent placement, coronary bypass surgery or any significant cardiac surgery, myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack
For Part C: have an automatic internal cardioverter-defibrillator
