A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tersolisib, High-fat Meal, Low-fat Meal.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Tersolisib
Tersolisib administered orally - Other High-fat Meal
High-fat Meal - Other Low-fat Meal
Low-fat Meal
Primary outcome measures
- 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]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Lenexa Clinic — Lenexa
- ICON Early Phase Services, LLC — San Antonio
Identifiers
NCT: NCT07662798 · 27883 · J6M-MC-JSGJ