Healthy VolunteersPhase 1NCT02271425
A Study to Measure the Amount of Evacetrapib That Enters the Blood Stream in Healthy Participants
A Phase 1 study testing Evacetrapib Tablet and Evacetrapib Intravenous in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
Evacetrapib (study drug) is an investigational drug being developed with the aim to help people at high risk of heart problems in the future. In this study we will be comparing how much of the study drug gets into the blood stream when it is given as a single dose (in tablet form) compared to an intravenous injection… 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?
- Evacetrapib Tablet and Evacetrapib Intravenous
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Nov 2014
- 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 overtly healthy males or females, as determined by medical history and physical examination
- Female participants are post menopausal women or women not of child bearing potential due to surgical sterilization (at least 6 weeks after surgical hysterectomy, bilateral oophorectomy, or tubal occlusion) confirmed by medical history, or menopause
- Have a body mass index (BMI) of less than 32 kilograms per square meter (kg/m^2)
- Have given written informed consent approved by Eli Lilly and Company and the ethical review board (ERB) governing the site
Who cannot join
- Have known allergies to evacetrapib, related compounds or any components of the formulation, intolerance to alcohol containing products, or history of significant allergic disease as determined by the investigator
- Have an abnormal blood pressure as determined by the investigator
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Are women who are pregnant or are lactating
Show all 11Show fewer
- Have used or intend to use over-the-counter or prescription medications (including vitamins/mineral supplements/herbal medicine) 14 days prior to the first dose and during the study. The use of topical medicine, provided there is no evidence of chronic dosing with risk of systemic exposure, and occasional acetaminophen is acceptable
- Have donated blood of more than 500 milliliter (mL) within the last 3 months
- Are unwilling to comply with the dietary requirements/restrictions during the study:
- Consume only the meals provided during the inpatient appointments,
- Refrain from eating any food or drinking any beverages containing grapefruit, grapefruit juice, Seville oranges, Seville orange juice, star fruit, pomelo, or commercial apple juice or orange juice for at least 7 days prior to the first dose
Trial locations and contacts
1 site in 1 country.
United Kingdom1 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.
Leeds, West Yorkshire, LS2 9LH
About this study
Official title: An Absolute Bioavailability Study of Evacetrapib in Healthy Subjects Using the Intravenous Tracer Method
Evacetrapib (study drug) is an investigational drug being developed with the aim to help people at high risk of heart problems in the future.
In this study we will be comparing how much of the study drug gets into the blood stream when it is given as a single dose (in tablet form) compared to an intravenous injection (given directly into a vein via a small needle).
The study is expected to last at least 15 days for each participant, not including screening. Screening will occur up to 28 days before the study drug is given.
- Conditions
- Healthy Volunteers
- Being tested
- Evacetrapib Tablet, Evacetrapib Intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evacetrapib TabletDrug
Also called LY2484595
Oral administration
Evacetrapib IntravenousDrug
Also called LY2484595
Intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| Evacetrapib Tablet + Evacetrapib Intravenous | Experimental | A single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)[¹³C₈] evacetrapib administered over a 4 hour infusion. Receives: Drug: Evacetrapib Tablet; Drug: Evacetrapib Intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Dose Normalized Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib
Measured: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.25, 4.5, 5, 5.5, 6, 6.5, 8, 10, 12, Day 2; 24, 36 Day 3; 48 Day 4; 72 Day 5; 96 Day 6; 120 Day 7; 144 and Day 8; 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
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 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
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
- NCT02271425
- Sponsor's protocol ID
- 14622
- Other IDs
- I1V-MC-EIAT
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2014
- Last updated
- 1 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Absolute Bioavailability Study of Evacetrapib in Healthy Subjects Using the Intravenous Tracer Method
- ClinicalTrials.gov ID
- NCT02271425
- Acronym / sponsor ID
- 14622
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 22 Oct 2014 (estimated)
- Results
- Posted 1 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evacetrapib (study drug) is an investigational drug being developed with the aim to help people at high risk of heart problems in the future.
In this study we will be comparing how much of the study drug gets into the blood stream when it is given as a single dose (in tablet form) compared to an intravenous injection (given directly into a vein via a small needle).
The study is expected to last at least 15 days for each participant, not including screening. Screening will occur up to 28 days before the study drug is given.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evacetrapib Tablet + Evacetrapib Intravenous | Experimental | Drug: Evacetrapib Tablet, Drug: Evacetrapib IntravenousA single oral dose of 130 milligrams (mg) evacetrapib tablet + a single intravenous (IV) dose of 175 micrograms (μg)[¹³C₈] evacetrapib administered over a 4 hour infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are overtly healthy males or females, as determined by medical history and physical examination
- Female participants are post menopausal women or women not of child bearing potential due to surgical sterilization (at least 6 weeks after surgical hysterectomy, bilateral oophorectomy, or tubal occlusion) confirmed by medical history, or menopause
- Have a body mass index (BMI) of less than 32 kilograms per square meter (kg/m^2)
- Have given written informed consent approved by Eli Lilly and Company and the ethical review board (ERB) governing the site
Key exclusion criteria (11 listed)
- Have known allergies to evacetrapib, related compounds or any components of the formulation, intolerance to alcohol containing products, or history of significant allergic disease as determined by the investigator
- Have an abnormal blood pressure as determined by the investigator
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
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 |
|---|---|---|
| Evacetrapib TabletAlso: LY2484595Oral administration | Drug | Evacetrapib Tablet + Evacetrapib Intravenous |
| Evacetrapib IntravenousAlso: LY2484595Intravenous administration | Drug | Evacetrapib Tablet + Evacetrapib Intravenous |
Primary outcome
Pharmacokinetics (PK): Dose Normalized Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib
Time frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.25, 4.5, 5, 5.5, 6, 6.5, 8, 10, 12, Day 2; 24, 36 Day 3; 48 Day 4; 72 Day 5; 96 Day 6; 120 Day 7; 144 and Day 8; 168 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Evacetrapib Tablet and Evacetrapib Intravenous in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.
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 4 inclusion and 11 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 1 Mar 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 United Kingdom. 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. 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 1 Mar 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?
Pharmacokinetics (PK): Dose Normalized Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Evacetrapib (time frame: Day 1:Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.25, 4.5, 5, 5.5, 6, 6.5, 8, 10, 12, Day 2; 24, 36 Day 3; 48 Day 4; 72 Day 5; 96 Day 6; 120 Day 7; 144 and Day 8; 168 hours post-dose). 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 1 Mar 2019.