HealthyPhase 1NCT04768842
A Study of Two Different Formulations of LY3209590 in Healthy Participants
A Phase 1 study testing LY3209590 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3209590
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Mar 2021to 3 Sep 2021
- 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
- Are overtly healthy males or non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy
- Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- Have veins suitable for blood sampling
- Have given written informed consent approved by Lilly and the ethical review board governing the site
Who cannot join
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Are women who are pregnant or lactating
- Have a history of multiple and/or severe allergic reactions
- Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive
- Regularly use known drugs of abuse or with positive drug results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Pharmacokinetics of LY3209590 After Administration of a Lyophilized Formulation and a Solution Formulation in Healthy Participants
The main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.
- Conditions
- Healthy
- Being tested
- LY3209590
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3209590Drug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3209590 Lyophilized Formulation | Experimental | LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods. Receives: Drug: LY3209590 |
| LY3209590 Solution Formulation | Experimental | LY3209590 as solution formulation administered SC in one of the two study periods. Receives: Drug: LY3209590 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590
PK: Cmax of LY3209590
Measured: Predose on Day 1 through Day 65
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590
PK: AUC(0-inf) of LY3209590
Measured: Predose on Day 1 through Day 65
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start3 Mar 2021
- Primary completion3 Sep 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 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
- NCT04768842
- Sponsor's protocol ID
- 16494
- Other IDs
- I8H-MC-BDCJ, 2020-003738-19
- Status last verified
- 15 Sep 2021
- First submitted
- 23 Feb 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetics of LY3209590 After Administration of a Lyophilized Formulation and a Solution Formulation in Healthy Participants
- ClinicalTrials.gov ID
- NCT04768842
- Acronym / sponsor ID
- 16494
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- 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 main purpose of this study is to look at the amount of the study drug, LY3209590, that gets into the blood stream and how long it takes the body to get rid of LY3209590 when given as different formulations. The tolerability of LY3209590 will also be evaluated and information about any side effects experienced will be collected. The study will last up to 142 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3209590 Lyophilized Formulation | Experimental | Drug: LY3209590LY3209590 as lyophilized formulation administered subcutaneously (SC) in one of the two study periods. |
| LY3209590 Solution Formulation | Experimental | Drug: LY3209590LY3209590 as solution formulation administered SC in one of the two study periods. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are overtly healthy males or non-pregnant females. Additionally, women of childbearing potential must test negative for pregnancy
- Have a body mass index (BMI) of 18 to 35 kilograms per square meter (kg/m²), inclusive at screening
- Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study
- Have veins suitable for blood sampling
- Have given written informed consent approved by Lilly and the ethical review board governing the site
Key exclusion criteria (5 listed)
- Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Are women who are pregnant or lactating
- Have a history of multiple and/or severe allergic reactions
- Show clinical evidence of HIV, hepatitis C, or hepatitis B, and/or test positive
- Regularly use known drugs of abuse or with positive drug results
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 |
|---|---|---|
| LY3209590Administered SC. | Drug | LY3209590 Lyophilized Formulation, LY3209590 Solution Formulation |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590
Time frame: Predose on Day 1 through Day 65
PK: Cmax of LY3209590
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3209590
Time frame: Predose on Day 1 through Day 65
PK: AUC(0-inf) of LY3209590
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 27 Sep 2021.
- Individual participant dataSharing planned: No
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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 LY3209590 in people with Healthy, 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 5 inclusion and 5 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 27 Sep 2021. 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?
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?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3209590 (time frame: Predose on Day 1 through Day 65). The study lists 2 primary outcomes in all. 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 27 Sep 2021.