HealthyPhase 1NCT07662798
A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants
A Phase 1 study testing Tersolisib, High-fat Meal and Low-fat Meal in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to measure how food affects the amount of tersolisib that gets into the bloodstream. Each participant will receive two single oral doses of tersolisib, one under fasted conditions and one with either a high-fat or a low-fat meal. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Tersolisib, High-fat Meal and Low-fat Meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2026to 3 Sep 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Are healthy as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations.
- Normal blood pressure and pulse rate.
- Body mass index (BMI) within the range 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive.
- Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).
Who cannot join
- History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee):
- Metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome
- Biliary disease, including cholecystectomy
- Gastrointestinal (GI) disease
- Hematological disease
- Neurological disease
Show all 10Show fewer
- Significant history of, or presence of liver disease, including abnormal liver function tests above 1.25 times the upper limit of normal range per the laboratory's reference ranges at screening or admission, or
- Clinically significant, active cardiovascular disease or history of myocardial infarction or significant cardiovascular disease.
- History of a major surgical procedure within 30 days prior to screening.
- Known allergies to tersolisib or related compounds.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lenexa Clinic
Lenexa, Kansas, 66219
ICON Early Phase Services, LLC
San Antonio, Texas, 78232
About this study
Official title: A Phase 1, Open-label Study to Assess the Effect of Food on the Pharmacokinetics of Tersolisib Administered Under Fasted Conditions, With a High-fat Meal, and With a Low-fat Meal, in Healthy Participants
The main purpose of this study is to measure how food affects the amount of tersolisib that gets into the bloodstream. Each participant will receive two single oral doses of tersolisib, one under fasted conditions and one with either a high-fat or a low-fat meal. Blood tests will be performed to investigate how the body processes the study drug under each condition. For each participant, the study will last about 9 weeks and will include a stay in the Clinical Research Unit (CRU) lasting almost a month.
- Conditions
- Healthy
- Being tested
- Tersolisib, High-fat Meal, Low-fat Meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TersolisibDrug
Also called LY4064809
Tersolisib administered orally
High-fat MealOther
High-fat Meal
Low-fat MealOther
Low-fat Meal
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Treatment A Fasted | Experimental | Tersolisib administered orally. Receives: Drug: Tersolisib |
| Group 1 Treatment B High-Fat Meal | Experimental | Tersolisib administered orally. Receives: Drug: Tersolisib; Other: High-fat Meal |
| Group 2 Treatment A Fasted | Experimental | Tersolisib administered orally. Receives: Drug: Tersolisib |
| Group 2 Treatment C Low-Fat Meal | Experimental | Tersolisib administered orally. Receives: Drug: Tersolisib; Other: Low-fat Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib
Measured: Predose on Day 1 Through Day 28
PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib
Measured: Predose on Day 1 Through Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Jul 2026
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
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
- None (open label)
- Enrolment
- 60 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662798
- Sponsor's protocol ID
- 27883
- Other IDs
- J6M-MC-JSGJ
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2026
- Last updated
- 14 Oct 2026
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Assess the Effect of Food on the Pharmacokinetics of Tersolisib Administered Under Fasted Conditions, With a High-fat Meal, and With a Low-fat Meal, in Healthy Participants
- ClinicalTrials.gov ID
- NCT07662798
- Acronym / sponsor ID
- 27883
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 23 Jun 2026 (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 measure how food affects the amount of tersolisib that gets into the bloodstream. Each participant will receive two single oral doses of tersolisib, one under fasted conditions and one with either a high-fat or a low-fat meal. Blood tests will be performed to investigate how the body processes the study drug under each condition. For each participant, the study will last about 9 weeks and will include a stay in the Clinical Research Unit (CRU) lasting almost a month.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 Treatment A Fasted | Experimental | Drug: TersolisibTersolisib administered orally. |
| Group 1 Treatment B High-Fat Meal | Experimental | Drug: Tersolisib, Other: High-fat MealTersolisib administered orally. |
| Group 2 Treatment A Fasted | Experimental | Drug: TersolisibTersolisib administered orally. |
| Group 2 Treatment C Low-Fat Meal | Experimental | Drug: Tersolisib, Other: Low-fat MealTersolisib administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Are healthy as determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations.
- Normal blood pressure and pulse rate.
- Body mass index (BMI) within the range 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive.
- Participants assigned male at birth (AMAB) or participants assigned female at birth (AFAB) who are individuals not of childbearing potential (INOCBP).
Key exclusion criteria (10 listed)
- History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee):
- History of a major surgical procedure within 30 days prior to screening.
- Known allergies to tersolisib or related compounds.
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 |
|---|---|---|
| TersolisibAlso: LY4064809Tersolisib administered orally | Drug | Group 1 Treatment A Fasted, Group 1 Treatment B High-Fat Meal, Group 2 Treatment A Fasted, Group 2 Treatment C Low-Fat Meal |
| High-fat MealHigh-fat Meal | Other | Group 1 Treatment B High-Fat Meal |
| Low-fat MealLow-fat Meal | Other | Group 2 Treatment C Low-Fat Meal |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib
Time frame: Predose on Day 1 Through Day 28
PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib
Time frame: Predose on Day 1 Through Day 28
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 14 Oct 2026.
- 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tersolisib, High-fat Meal and Low-fat Meal in people with Healthy, run by Eli Lilly and Company at 2 sites in United States.
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 10 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Tersolisib (time frame: Predose on Day 1 Through Day 28). 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 14 Oct 2026.