Healthy VolunteersPhase 1NCT02327143
A Study of LY2835219 in Healthy Participants
A Phase 1 study testing LY2835219 and ¹³C₈-LY2835219 in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle). 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?
- LY2835219 and ¹³C₈-LY2835219
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Feb 2015
- 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
- Overtly healthy sterile males or surgically sterile females or postmenopausal females
- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)
- Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
- Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Who cannot join
- Have participated in a clinical trial involving investigational product within the last 90 days
- 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
- Have an abnormal blood pressure
- Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Have donated blood of more than 500 milliliters (mL) within the last month
- Have consumed any sensitive CYP2B6 substrate drugs, any CYP3A4 inhibitor or any CYP3A inducer, herbal supplements, grapefruits or grapefruit containing products, Seville oranges or Seville orange containing products, star fruits or star fruit containing products within 2 weeks prior to dosing or intend to consume during the study
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
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, LS2 9LH
About this study
Official title: An Absolute Bioavailability Study of LY2835219 in Healthy Subjects Using the Intravenous Tracer Method
The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle).
The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function.
The study will last about 10 days. Screening is required within 28 days before study drug is given.
- Conditions
- Healthy Volunteers
- Being tested
- LY2835219, ¹³C₈-LY2835219
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2835219Drug
Administered orally
¹³C₈-LY2835219Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| 200 mg LY2835219 | Experimental | 200 mg LY2835219 administered orally on day 1. Receives: Drug: LY2835219 |
| 0.4 mg ¹³C₈-LY2835219 | Experimental | 0.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose. Receives: Drug: ¹³C₈-LY2835219 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219
Measured: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
Secondary outcomes (2)
PK: Maximum Observed Concentration (Cmax) of LY2835219
Measured: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219
Measured: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionFeb 2015
- Study completionFeb 2015
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 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
- NCT02327143
- Sponsor's protocol ID
- 15533
- Other IDs
- I3Y-MC-JPBS
- Status last verified
- Oct 2017
- First submitted
- 23 Dec 2014
- Last updated
- 6 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Absolute Bioavailability Study of LY2835219 in Healthy Subjects Using the Intravenous Tracer Method
- ClinicalTrials.gov ID
- NCT02327143
- Acronym / sponsor ID
- 15533
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Posted 6 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare how much of the study drug gets into the blood stream when it is given as a single oral dose and as an intravenous infusion (given directly into a vein via a small needle).
The study will also provide information on how well the study drug is tolerated when given as a capsule in combination with giving it intravenously, and information on any changes in heart function.
The study will last about 10 days. Screening is required within 28 days before study drug is given.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 200 mg LY2835219 | Experimental | Drug: LY2835219200 mg LY2835219 administered orally on day 1. |
| 0.4 mg ¹³C₈-LY2835219 | Experimental | Drug: ¹³C₈-LY28352190.4 mg ¹³C₈-LY2835219 given intravenously (IV) for 15 minutes, starting approximately 6 hours after the oral dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Overtly healthy sterile males or surgically sterile females or postmenopausal females
- Have a body mass index (BMI) of 18 to 32 kilogram per meter square (kg/m^2)
- Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site.
- Participants who are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Key exclusion criteria (7 listed)
- Have participated in a clinical trial involving investigational product within the last 90 days
- 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
- Have an abnormal blood pressure
- Show evidence of human immunodeficiency virus (HIV), hepatitis B or hepatitis C
- Have donated blood of more than 500 milliliters (mL) within the last month
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 |
|---|---|---|
| LY2835219Administered orally | Drug | 200 mg LY2835219 |
| ¹³C₈-LY2835219Administered IV | Drug | 0.4 mg ¹³C₈-LY2835219 |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219
Time frame: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
2 secondary outcomes
PK: Maximum Observed Concentration (Cmax) of LY2835219
Time frame: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
PK: Time of Maximum Observed Drug Concentration (Tmax) of LY2835219
Time frame: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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 LY2835219 and ¹³C₈-LY2835219 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 7 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 6 Aug 2018. 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 6 Aug 2018). 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): Area Under the Concentration-Time Curve From Zero to Infinity [AUC(0-∞)] of LY2835219 and ¹³C₈-LY2835219 (time frame: Predose, 2, 4, 6, 6.25, 6.5, 6.75, 7.25, 8.25,10, 12, 14, 24, 48, 72, 96,120, 144, 168,192 Hours Postdose). 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 6 Aug 2018.