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| ID | Type | Description | Link |
|---|---|---|---|
| I6S-MC-ASEB | Other Identifier | Eli Lilly and Company | |
| 2013-000475-32 | EudraCT Number |
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The purpose of this study is to investigate the safety and tolerability of LY3045697 after multiple doses and to determine how long LY3045697 remains in the body. Each participant is expected to complete 3 dosing periods. At least 7 days will pass between dosing periods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY3045697 | Experimental | Escalating dose (0.1 milligrams [mg] up to 100 mg) of LY3045697 administered once daily, orally, for 8 days in 2 of 3 dosing periods |
|
| Spironolactone | Active Comparator | 25 mg spironolactone administered once daily, orally, for 8 days in up to 1 of 3 dosing periods |
|
| Placebo | Placebo Comparator | Placebo matching LY3045697 administered once daily, orally for 8 days in up to 1 of 3 dosing periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3045697 | Drug | Administered as oral solution |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Clinically Significant Adverse Events (AEs) or Any Serious AEs | Baseline to 10 days post last dose (Estimated up to 8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3045697 | Predose to 24 hours after dosing on Day 8 of each dosing period | |
| Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) from Zero to Infinity (AUC 0-∞) of LY3045697 | Predose to 24 hours after dosing on Day 8 of each dosing period |
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Inclusion Criteria:
Exclusion Criteria:
Are currently enrolled in, or discontinued within the last 60 days prior to drug administration inclusive from, a clinical trial involving an investigational drug that has not received regulatory approval for any indication
Have previously completed or withdrawn from this study or any other study investigating this study drug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, renal, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator, indicates a medical problem that would preclude study participation
Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study, such as a prolonged PR or QRS interval. In addition, participants with the following findings will be excluded:
Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or hepatitis B and/or positive hepatitis B surface antigen (HBsAg)
Intend to use over-the-counter or prescription medication within 5 days prior to dosing, other than daily multi-vitamin therapy, stable thyroid hormone replacement or medication assessed as acceptable by the investigator and not interfering with the integrity of the study data collection. Medications for benign indications in healthy participants may be continued, with the exception of drugs that may alter adrenal function, blood pressure or potassium, such as the use of excessive non-steroidal anti-inflammatory drugs (NSAIDs), glucocorticoids, diuretics, antihypertensive drugs, beta-agonists, and nasal decongestants
Have donated blood of more than 500 milliliters (mL) within 60 days prior to dosing. Donation of more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months preceding the start of this study (this is the first administration of study drug)
Have an average weekly alcohol intake that exceeds 21 units per week or participants unwilling to stop alcohol within 48 hours of entry into study until discharge each period [1 unit = 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 (DBP) >95 or less than (<) 50 millimeter of mercury (mmHg) and/or systolic blood pressure (SBP) >150 or <90 mmHg confirmed by at least 1 repeat measurement
Regularly use known drugs of abuse or show positive findings for such use on urinary drug screening
Use of natural licorice (glycyrrhizinic acid) within 5 days of enrollment or use during the study
Are unwilling to abstain from using grapefruit-containing products and salt-substitutes containing potassium for the duration of the study
Have known sensitivity or are unable to tolerate spironolactone
Have serum potassium >upper limit of normal (result from suspected hemolyzed sample may be repeated)
Have serum sodium <lower limit of normal per lab reference range
Have serum creatinine >124 micromole/liter (μmol/L) (male); >106 μmol/L (female)
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 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. | Zuidlaren | 9471 GP |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Drug |
Administered as oral solution |
|
| Spironolactone | Drug | Administered as capsule |
|
| Placebo | Drug | Administered as capsule |
|
| Netherlands |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |