HealthyPhase 1NCT05615532
A Relative Bioavailability Study of LY3209590 in Healthy Participants
A Phase 1 study testing LY3209590 (SC) and LY3209590 (IV) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The study will be conducted in two parts (part A and part B). The main purpose of this study is to compare the amount of LY3209590 that gets into the blood stream and how long it takes the body to get rid of it, when self-administered at different body sites, abdominal wall, upper arm and thigh (part A), when… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3209590 (SC) and LY3209590 (IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Nov 2022to 28 Jun 2023
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants who are overtly healthy as determined by medical evaluation
- Participants with body mass index (BMI) within the range 18.5 to 35.0 kilograms per meter squared (kg/m²)
- Male or female participants must agree to use contraception
Who cannot join
- Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
- Have known allergies to LY3209590, related compounds, or any components of the formulation
- Have an abnormality in the 12-lead electrocardiogram
- Intend to use prescription medication, including herbal medications and traditional medications
- Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antibodies, hepatitis C or positive hepatitis C antibody, or hepatitis B or positive hepatitis B surface antigen
- Are lactating or pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Injection Site on the Relative Bioavailability of Single Dose of LY3209590 and Evaluation of Absolute Bioavailability of LY3209590 in Healthy Participants
The study will be conducted in two parts (part A and part B). The main purpose of this study is to compare the amount of LY3209590 that gets into the blood stream and how long it takes the body to get rid of it, when self-administered at different body sites, abdominal wall, upper arm and thigh (part A), when administered by two different routes of injection, subcutaneously or intravenously (part B) in healthy participants.
The study may last up to 65 (part A) and 184 (part B) days, respectively.
- Conditions
- Healthy
- Being tested
- LY3209590 (SC), LY3209590 (IV)
- Keywords
- Bioavailability, Injection sites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3209590 (SC)Drug
Administered SC.
LY3209590 (IV)Drug
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| LY3209590 (Part A - Upper Arm) | Experimental | LY3209590 administered subcutaneously (SC) into the upper arm Receives: Drug: LY3209590 (SC) |
| LY3209590 (Part A - Thigh) | Experimental | LY3209590 administered SC into the thigh Receives: Drug: LY3209590 (SC) |
| LY3209590 (Part A - Abdominal Wall) | Experimental | LY3209590 administered SC into the abdominal wall Receives: Drug: LY3209590 (SC) |
| LY3209590 (Part B - IV Dose) | Experimental | LY3209590 administered intravenously (IV) Receives: Drug: LY3209590 (IV) |
| LY3209590 (Part B - SC Dose) | Experimental | LY3209590 administered SC into the abdominal wall Receives: Drug: LY3209590 (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
Part A: PK: AUC0-∞ of LY3209590
Measured: Predose on Day 1 through Day 65
Secondary outcomes (1)
Part B: PK: AUC0-∞ of LY3209590
Part B: PK: AUC0-∞ 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 posted14 Nov 2022
- Study start11 Nov 2022
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
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
- Parallel groups
- Model description
- Part A is Parallel design and Part B is a crossover design
- Masking
- None (open label)
- Enrolment
- 168 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
- NCT05615532
- Sponsor's protocol ID
- 18222
- Other IDs
- I8H-MC-BDDD
- Status last verified
- Jun 2024
- First submitted
- 10 Nov 2022
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Injection Site on the Relative Bioavailability of Single Dose of LY3209590 and Evaluation of Absolute Bioavailability of LY3209590 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05615532
- Acronym / sponsor ID
- 18222
- Conditions
- Healthy
- Keywords
- Bioavailability, Injection sites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 14 Nov 2022 (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 study will be conducted in two parts (part A and part B). The main purpose of this study is to compare the amount of LY3209590 that gets into the blood stream and how long it takes the body to get rid of it, when self-administered at different body sites, abdominal wall, upper arm and thigh (part A), when administered by two different routes of injection, subcutaneously or intravenously (part B) in healthy participants.
The study may last up to 65 (part A) and 184 (part B) days, respectively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Part A is Parallel design and Part B is a crossover design
| Arm | Type | Receives |
|---|---|---|
| LY3209590 (Part A - Upper Arm) | Experimental | Drug: LY3209590 (SC)LY3209590 administered subcutaneously (SC) into the upper arm |
| LY3209590 (Part A - Thigh) | Experimental | Drug: LY3209590 (SC)LY3209590 administered SC into the thigh |
| LY3209590 (Part A - Abdominal Wall) | Experimental | Drug: LY3209590 (SC)LY3209590 administered SC into the abdominal wall |
| LY3209590 (Part B - IV Dose) | Experimental | Drug: LY3209590 (IV)LY3209590 administered intravenously (IV) |
| LY3209590 (Part B - SC Dose) | Experimental | Drug: LY3209590 (SC)LY3209590 administered SC into the abdominal wall |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants who are overtly healthy as determined by medical evaluation
- Participants with body mass index (BMI) within the range 18.5 to 35.0 kilograms per meter squared (kg/m²)
- Male or female participants must agree to use contraception
Key exclusion criteria (6 listed)
- Have a history of multiple or severe allergic reactions or a history of severe anaphylactic reaction
- Have known allergies to LY3209590, related compounds, or any components of the formulation
- Have an abnormality in the 12-lead electrocardiogram
- Intend to use prescription medication, including herbal medications and traditional medications
- Show evidence of human immunodeficiency virus infection or positive human immunodeficiency virus antibodies, hepatitis C or positive hepatitis C antibody, or hepatitis B or positive hepatitis B surface antigen
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 |
|---|---|---|
| LY3209590 (SC)Administered SC. | Drug | LY3209590 (Part A - Abdominal Wall), LY3209590 (Part A - Thigh), LY3209590 (Part A - Upper Arm), LY3209590 (Part B - SC Dose) |
| LY3209590 (IV)Administered IV. | Drug | LY3209590 (Part B - IV Dose) |
Primary outcome
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590
Time frame: Predose on Day 1 through Day 65
Part A: PK: AUC0-∞ of LY3209590
1 secondary outcome
Part B: PK: AUC0-∞ of LY3209590
Time frame: Predose on Day 1 through Day 65
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 12 Jun 2024.
- 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 (SC) and LY3209590 (IV) in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 3 inclusion and 6 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 12 Jun 2024. 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 Singapore. 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?
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3209590 (time frame: Predose on Day 1 through Day 65). 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 12 Jun 2024.