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
Eli Lilly and Company
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.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- 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, d…
Interventions
- DrugTersolisib
Tersolisib administered orally
- OtherHigh-fat Meal
High-fat Meal
- OtherLow-fat Meal
Low-fat Meal
Locations (2)
- Lenexa ClinicLenexa, Kansas
- ICON Early Phase Services, LLCSan Antonio, Texas