Healthy
Conditions
Brief 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. 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
DRUGTersolisib
Tersolisib administered orally
OTHERHigh-fat Meal
High-fat Meal
OTHERLow-fat Meal
Low-fat Meal
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tersolisib | Predose on Day 1 Through Day 28 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of Tersolisib | Predose on Day 1 Through Day 28 |
Countries
United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Outcome results
None listed