Healthy VolunteersPhase 1NCT01821703
A Study of LY3045697 After Multiple Oral Dosing in Healthy Participants
A Phase 1 study testing LY3045697 and Spironolactone in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- LY3045697 and Spironolactone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2013to Sep 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy men and women of non-child bearing potential as determined by medical history and physical examination
- Male participants must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days after the end of the final dosing
- Female participants must be postmenopausal or surgically sterile
- Postmenopausal female participants must be between the ages of 45 and 65 years inclusive, and must be 12 months without a menstrual period, or 6-12 months without a menstrual period and Follicle-Stimulating Hormone (FSH) greater than (>)40 International Units per Liter (IU/L)
- Male participants and surgically sterile females are between the ages of 18 and 65 years inclusive
- Have a Body Mass Index (BMI) between 18.0 and 32.5 kilograms per square meter (kg/m2), inclusive, at screening
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- 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
- Have venous access sufficient to allow blood sampling
- Are non-smokers or a smoker of 5 or less cigarettes/cigars/pipes per day as determined by history
- Have the ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "power drinks"), poppy seed and tobacco products from 48 hours prior to entry in the clinical research facility until discharge
Who cannot join
- 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:
- Confirmed corrected QT (QTcF) interval >450 millisecond (msec) for men and >470 msec for women; additional ECGs may be performed if required
- Complete bundle branch blocks and other conduction abnormalities other than mild first degree atrio-ventricular block
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- Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
- History of unexplained syncope
- Family history of unexplained sudden death or sudden death due to long QT syndrome
- T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator
- 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)
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
About this study
Official title: A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3045697 After Multiple Oral Dosing in Healthy Subjects
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.
- Conditions
- Healthy Volunteers
- Being tested
- LY3045697, Placebo, Spironolactone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3045697Drug
Administered as oral solution
PlaceboDrug
Administered as oral solution
SpironolactoneDrug
Administered as capsule
PlaceboDrug
Administered as capsule
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: LY3045697 |
| Spironolactone | Active comparator | 25 mg spironolactone administered once daily, orally, for 8 days in up to 1 of 3 dosing periods Receives: Drug: Spironolactone |
| Placebo | Placebo comparator | Placebo matching LY3045697 administered once daily, orally for 8 days in up to 1 of 3 dosing periods Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Clinically Significant Adverse Events (AEs) or Any Serious AEs
Measured: Baseline to 10 days post last dose (Estimated up to 8 weeks)
Secondary outcomes (2)
Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3045697
Measured: 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
Measured: Predose to 24 hours after dosing on Day 8 of each dosing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821703
- Sponsor's protocol ID
- 15051
- Other IDs
- I6S-MC-ASEB, 2013-000475-32
- Status last verified
- Oct 2013
- First submitted
- 27 Mar 2013
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3045697 After Multiple Oral Dosing in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01821703
- Acronym / sponsor ID
- 15051
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3045697 | Experimental | Drug: LY3045697Escalating 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 | Drug: Spironolactone25 mg spironolactone administered once daily, orally, for 8 days in up to 1 of 3 dosing periods |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo matching LY3045697 administered once daily, orally for 8 days in up to 1 of 3 dosing periods |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy men and women of non-child bearing potential as determined by medical history and physical examination
- Male participants must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days after the end of the final dosing
- Female participants must be postmenopausal or surgically sterile
- Postmenopausal female participants must be between the ages of 45 and 65 years inclusive, and must be 12 months without a menstrual period, or 6-12 months without a menstrual period and Follicle-Stimulating Hormone (FSH) greater than (>)40 International Units per Liter (IU/L)
- Male participants and surgically sterile females are between the ages of 18 and 65 years inclusive
Key exclusion criteria (22 listed)
- 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)
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 |
|---|---|---|
| LY3045697Administered as oral solution | Drug | LY3045697 |
| PlaceboAdministered as oral solution | Drug | Placebo |
| SpironolactoneAdministered as capsule | Drug | Spironolactone |
| PlaceboAdministered as capsule | Drug | Placebo |
Primary outcome
Number of Participants with One or More Clinically Significant Adverse Events (AEs) or Any Serious AEs
Time frame: Baseline to 10 days post last dose (Estimated up to 8 weeks)
2 secondary outcomes
Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3045697
Time frame: 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
Time frame: Predose to 24 hours after dosing on Day 8 of each dosing period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2013.
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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 LY3045697 and Spironolactone in people with Healthy Volunteers, 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 22 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 10 Oct 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 One or More Clinically Significant Adverse Events (AEs) or Any Serious AEs (time frame: Baseline to 10 days post last dose (Estimated up to 8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2013.