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HealthyPhase 1NCT04682119

A Safety Study of LY3526318 in Healthy Participants

A Phase 1 study testing LY3526318 in people with Healthy, run by Eli Lilly and Company at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. 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?
LY3526318
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteNetherlands
Study dates
29 Dec 2020to 21 Apr 2021
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 through medical history and physical examination
  • Have a body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m²)
  • Have clinical laboratory test results within normal reference range

Who cannot join

  • Have a history or presence of medical illness including, but not limited to, cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, convulsions, or any clinically significant laboratory abnormality
  • Have an abnormality in the 12-lead electrocardiogram (ECG)
  • Have a history of clinically significant multiple or severe drug allergies
  • 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.
  • Have an abnormal blood pressure
  • Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer)
Show all 9Show fewer
  • Are unwilling to stop herbal supplements, over the counter or prescription medicines
  • Are currently enrolled in a clinical drug study or any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Participants with a history of drug abuse

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA Health Sciences

    Groningen, 9728

Other trials in Netherlands

About this study

Official title: A Safety, Tolerability and Pharmacokinetic Study of Single and Multiple Doses of LY3526318 in Healthy Participants

The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 44 days and Part B will last up to 50 days, including screening and follow-up.

Conditions
Healthy
Being tested
LY3526318, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3526318Drug

    Administered orally.

  • PlaceboDrug

    Administered orally.

Study groups in NCT04682119
Study groupRoleWhat they receive
LY3526318 (Part A)Experimental250 mg, 100 milligram (mg) LY3526318 administered orally as single ascending doses under fasted or fed condition.
Receives: Drug: LY3526318
LY3526318 (Part B)Experimental250 mg LY3526318 administered orally as multiple doses under fasted or fed condition.
Receives: Drug: LY3526318
Placebo (Part A)Placebo comparatorPlacebo administered orally under fasted or fed condition.
Receives: Drug: Placebo
Placebo (Part B)Placebo comparatorPlacebo administered orally under fasted or fed condition.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318

    Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318

    Measured: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

  2. Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

    Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

    Measured: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

  3. Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318

    Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318

    Measured: Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose

  4. Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

    Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318

    Measured: Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose

Secondary outcomes (5)

  1. Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.

    Measured: Single oral dose to up to 11 days of follow-up

  2. Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.

    Measured: Up to 14 days following first dose

  3. Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax)

    Part A, Effect of a meal on pharmacokinetics of LY3526318: Maximum Concentration (Cmax)

    Measured: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

  4. Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞)

    Part A, Effect of a meal on pharmacokinetics of LY3526318: Area under the concentration time curve from time 0 to infinity (AUC 0-∞)

    Measured: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

  5. Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)

    Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)

    Measured: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2020
  2. Study start29 Dec 2020
  3. Primary completion21 Apr 2021
  4. Study completion21 Apr 2021

Resources

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
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04682119
Sponsor's protocol ID
17807
Other IDs
2020-004290-46, J2D-MC-CVAC
Status last verified
1 Aug 2025
First submitted
22 Dec 2020
Last updated
10 Sep 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3526318 in people with Healthy, 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 3 inclusion and 9 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 Sep 2025. 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?

Yes. Results are posted in the registry (first posted 10 Sep 2025). 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?

Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318 (time frame: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04682119.

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 Sep 2025.

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