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Trial record 85 of 112 for:    EPLERENONE

Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance

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ClinicalTrials.gov Identifier: NCT01237899
Recruitment Status : Completed
First Posted : November 10, 2010
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to investigate the safety and tolerability of LY2623091 after multiple oral dosing in healthy men and women of non-childbearing potential. Two cohorts of 16 subjects will participate in 2 dosing periods. Treatment assignment will be double-blind for LY2623091 and placebo (negative control), and open label for eplerenone (positive control).

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: LY2623091 Drug: Placebo Drug: Eplerenone Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance After Multiple Oral Dosing of LY2623091 in Healthy Volunteers
Study Start Date : October 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Potassium
Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: 1 mg LY2623091
Daily by mouth for 7 days.
Drug: LY2623091
Administered orally.

Experimental: 10 mg LY2623091
Daily by mouth for 7 days.
Drug: LY2623091
Administered orally.

Experimental: 25 mg LY2623091
The anticipated dose of LY2623091 was revised down from the original proposed dose level of 100 mg based on safety and tolerability data. The 25 mg LY2623091 was administered daily by mouth for 7 days.
Drug: LY2623091
Administered orally.

Experimental: 0.3 mg LY2623091
The anticipated dose of LY2623091 was revised down from the original proposed dose level of up to 200 mg. The 0.3 mg LY2623091 was determined based on an interim analysis after the third dose level and was administered daily by mouth for 7 days.
Drug: LY2623091
Administered orally.

Placebo Comparator: Placebo
Daily by mouth for 7 days.
Drug: Placebo
Administered orally.

Active Comparator: 50 mg Eplerenone
Daily by mouth for 7 days.
Drug: Eplerenone
Administered orally.




Primary Outcome Measures :
  1. Number of Participants With Clinically Significant Effects (Adverse Events) [ Time Frame: Baseline through 7 days for each treatment period ]
    A summary of serious adverse events and other nonserious adverse events are located in the Reported Adverse Event section.


Secondary Outcome Measures :
  1. Pharmacodynamics: Serum to Urine Potassium Area Under the Concentration-Time Curve (AUC) Standardized for Urinary Excretion at Day 7 [ Time Frame: Day 7: 24 Hour (hr), 48hr and 72hr Postdose ]
    A measure of the renal clearance of the potassium ion (K+). The Least Squares (LS) Mean value was adjusted for pre-challenge renal K+ clearance.

  2. Pharmacokinetics of LY2623091: Maximal Concentration (Cmax) at Day 6 [ Time Frame: Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose ]
    Cmax estimated for LY2623091.

  3. Pharmacokinetics LY2623091: Area Under the Concentration-Time Curve (AUC) at Day 6 [ Time Frame: Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose ]
    AUC from time 0, extrapolated to infinity, estimated for LY2623091.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Are healthy men and women of non-childbearing potential as determined by medical history and physical examination.

    • Male subjects: Non-vasectomized male subjects must agree to use 2 medically accepted methods of contraception with all sexual partners during the study and for 90 days following the final dosing.
    • Female subjects: Female subjects must be of non-childbearing potential due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation) or menopause. They should be a minimum of 12 months without a menstrual period. Peri-menopausal women who are 6 months without a menstrual period.
  • Have given written informed consent prior to any study-specific procedures.
  • 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) of between 19 and 32.5 kilograms per square meter (kg/m^2).
  • Have clinical laboratory test results within the normal reference range for the population or study site, or test results with acceptable deviations that are judged by the Investigator not to be clinically significant.
  • Have venous access sufficient to allow blood sampling per the protocol.
  • Have serum potassium levels within the normal range.
  • Are nonsmokers or smokers of less than or equal to 10 cigarettes per day.

Exclusion Criteria:

  • Are currently enrolled in, or have discontinued, within 60 days inclusive, a clinical trial involving an investigational drug, device or an off-label use of an approved drug, or are concurrently enrolled in any other type of medical research judged to be scientifically or medically incompatible with this study. Subjects who meet any of these criteria may be enrolled in this study but they cannot be dosed until at least 60 days following the last day of the previous investigational trial.
  • Have previously completed or withdrawn from this study or any other study investigating LY2623091.
  • Have a history or presence of medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine or neurological disease, or any clinically significant laboratory abnormality that is of a serious medical problem that would preclude study participation.
  • Have an abnormality in the 12-lead electrocardiogram (ECG), which increases the risks associated with participation in the study.
  • Are unwilling or unable to comply with the use of an electronic data capture system.
  • 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.
  • Use and/or intend to use any medication for a medical condition that is not compatible with Inclusion Criterion. For medications that may be used in "healthy‟ subjects (example given: preventative and/or naturopathic agents, temporary symptom-relieving medications, and so forth) the following constraints must be observed:

    • No use of vasoactive drugs (example given: diuretics, antihypertensive agents, phosphodiesterase inhibitors, erectile dysfunction medications, nasal decongestants, et cetera) or systemic glucocorticoids within 7 days of first dosing and/or anticipated use during the study.
    • No use of acetaminophen/paracetamol or non-steroidal anti-inflammatory drugs (NSAIDs) within 24 hours of first dosing and/or anticipated use during the study. Aspirin may not be used at doses greater than 100 milligrams per day (mg/day) within 7days of first dosing and/or anticipated use during the study.
    • No use of herbal or nutritional products within 7 days of first dosing and/or anticipated use during the study.
  • Have donated blood of more than 50 milliliters (mL) within the last 60 days.
  • Have an average weekly alcohol intake that exceeds 21 units per week and/or subjects unwilling to stop alcohol within 48 hours of study enrollment and for the duration of the study.
  • Have an abnormally high blood pressure (supine or standing) defined as diastolic blood pressure greater than 95 millimeters of mercury (mmHg) and /or systolic blood pressure greater than 150 mmHg, confirmed by at least 1 repeat measurement.
  • Have serum potassium greater than the upper limit of normal.
  • Regularly use known drugs of abuse or show positive findings for such use on urinary drug screening.
  • Consumption of natural licorice and/or natural licorice-containing products and/or grapefruit and/or grapefruit juice within 7 days of first dosing and/or anticipated consumption during the study.
  • Consumption of methylxanthine-containing beverages and/or foods (example: coffee, tea, caffeinated soft drinks, chocolate) within 4 days of first dosing and/or anticipated consumption during the study.
  • Are unwilling to abstain from salt-substitutes containing potassium for the duration of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237899


Locations
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Netherlands
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, Netherlands, 9471 GP
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01237899     History of Changes
Other Study ID Numbers: 14121
I4M-MC-MRAB ( Other Identifier: Eli Lilly )
First Posted: November 10, 2010    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Keywords provided by Eli Lilly and Company:
Kidney
Renal
Additional relevant MeSH terms:
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Eplerenone
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents