Chronic Kidney DiseasePhase 1NCT01237899

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

A Phase 1 study testing LY2623091 and Eplerenone in people with Chronic Kidney Disease, run by Eli Lilly and Company at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Kidney Disease
What is being tested?: LY2623091 and Eplerenone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteNetherlands
Study dates: Oct 2010to Jan 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

Show all 10Show fewer

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.

Who cannot join

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.

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

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

Other trials in Netherlands

About this study

Official title: Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance After Multiple Oral Dosing of LY2623091 in Healthy Volunteers

Conditions: Chronic Kidney Disease
Being tested: LY2623091, Placebo, Eplerenone
Keywords: Kidney, Renal
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2623091Drug
Administered orally.
PlaceboDrug
Administered orally.
EplerenoneDrug
Administered orally.

Study groups in NCT01237899
Study group	Role	What they receive
1 mg LY2623091	Experimental	Daily by mouth for 7 days. Receives: Drug: LY2623091
10 mg LY2623091	Experimental	Daily by mouth for 7 days. Receives: Drug: LY2623091
25 mg LY2623091	Experimental	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. Receives: Drug: LY2623091
0.3 mg LY2623091	Experimental	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. Receives: Drug: LY2623091
Placebo	Placebo comparator	Daily by mouth for 7 days. Receives: Drug: Placebo
50 mg Eplerenone	Active comparator	Daily by mouth for 7 days. Receives: Drug: Eplerenone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

Pharmacodynamics: Serum to Urine Potassium Area Under the Concentration-Time Curve (AUC) Standardized for Urinary Excretion at Day 7
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.
Measured: Day 7: 24 Hour (hr), 48hr and 72hr Postdose
Pharmacokinetics of LY2623091: Maximal Concentration (Cmax) at Day 6
Cmax estimated for LY2623091.
Measured: Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose
Pharmacokinetics LY2623091: Area Under the Concentration-Time Curve (AUC) at Day 6
AUC from time 0, extrapolated to infinity, estimated for LY2623091.
Measured: Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Jan 2011

First posted10 Nov 2010 (estimated)
Study startOct 2010
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01237899
Sponsor's protocol ID: 14121
Other IDs: I4M-MC-MRAB
Status last verified: Feb 2019
First submitted: 8 Nov 2010
Last updated: 3 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Chronic Kidney Disease
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease

All Chronic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Safety, Tolerability, Pharmacokinetics and Effect on Renal Potassium Clearance After Multiple Oral Dosing of LY2623091 in Healthy Volunteers
ClinicalTrials.gov ID: NCT01237899
Acronym / sponsor ID: 14121
Conditions: Chronic Kidney Disease
Keywords: Kidney, Renal
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 10 Nov 2010 (estimated)
Results: Posted 3 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
1 mg LY2623091	Experimental	Drug: LY2623091Daily by mouth for 7 days.
10 mg LY2623091	Experimental	Drug: LY2623091Daily by mouth for 7 days.
25 mg LY2623091	Experimental	Drug: LY2623091The 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.
0.3 mg LY2623091	Experimental	Drug: LY2623091The 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.
Placebo	Placebo comparator	Drug: PlaceboDaily by mouth for 7 days.
50 mg Eplerenone	Active comparator	Drug: EplerenoneDaily by mouth for 7 days.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (18 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2623091Administered orally.	Drug	0.3 mg LY2623091, 1 mg LY2623091, 10 mg LY2623091, 25 mg LY2623091
PlaceboAdministered orally.	Drug	Placebo
EplerenoneAdministered orally.	Drug	50 mg Eplerenone

Primary outcome

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.

3 secondary outcomes

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
Pharmacokinetics of LY2623091: Maximal Concentration (Cmax) at Day 6
Time frame: Day 6: Predose,1hr, 2hr, 3hr, 4hr, 8hr and 12 hr Postdose
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

Results and safety

Results posted to the registry on 3 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1 mg LY2623091 First Then 25 mg LY2623091	1	1
1 mg LY2623091 First Then Placebo	3	3
1 mg LY2623091 First Then 50 mg Eplerenone	4	4
50 mg Eplerenone First Then 25 mg LY2623091	3	3
50 mg Eplerenone First Then Placebo	2	2
Placebo First Then 25 mg LY2623091	4	4
10 mg LY2623091 First Then 0.3 mg LY2623091	1	1
10 mg LY2623091 First Then Placebo	3	3
10 mg LY2623091 First Then 50 mg Eplerenone	4	4
50 mg Eplerenone First Then 0.3 mg LY2623091	3	3
Placebo Then 0.3 mg LY2623091	4	4

Primary outcome: Number of Participants With Clinically Significant Effects (Adverse Events)

Time frame: Baseline through 7 days for each treatment period. Count of participants. Unit: Participants

Measure	Placebo n = 16	0.3 mg LY2623091 n = 8	1 mg LY2623091 n = 8	10 mg LY2623091 n = 8	25 mg LY2623091 n = 8	50 mg Eplerenone n = 15
Serious Adverse Events	0	0	0	0	0	0
Nonserious Adverse Events	6	2	5	4	6	9

Population analysed: All participants who received at least 1 dose of study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	6 of 16 (37.5%)	Not reported
0.3 mg LY2623091	0 of 8 (0%)	2 of 8 (25%)	Not reported
1 mg LY2623091	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
10 mg LY2623091	0 of 8 (0%)	4 of 8 (50%)	Not reported
25 mg LY2623091	0 of 8 (0%)	6 of 8 (75%)	Not reported
50 mg Eplerenone	0 of 15 (0%)	9 of 15 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Kidney Disease

RecruitingObservational study
Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors
Chronic Kidney Disease
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
RecruitingObservational study
Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation
Cardiovascular Diseases, Kidney Transplant; Complications
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
Recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population
Chronic Kidney Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY2623091 and Eplerenone in people with Chronic Kidney Disease, run by Eli Lilly and Company at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Clinically Significant Effects (Adverse Events) (time frame: Baseline through 7 days for each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01237899.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.