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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1 Treatment A Fasted 		Tersolisib administered orally.
  • Drug: Tersolisib
    Tersolisib administered orally
    Other names:
    • LY4064809
Experimental
Group 1 Treatment B High-Fat Meal 		Tersolisib administered orally.
  • Drug: Tersolisib
    Tersolisib administered orally
    Other names:
    • LY4064809
  • Other: High-fat Meal
    High-fat Meal
Experimental
Group 2 Treatment A Fasted 		Tersolisib administered orally.
  • Drug: Tersolisib
    Tersolisib administered orally
    Other names:
    • LY4064809
Experimental
Group 2 Treatment C Low-Fat Meal 		Tersolisib administered orally.
  • Drug: Tersolisib
    Tersolisib administered orally
    Other names:
    • LY4064809
  • Other: Low-fat Meal
    Low-fat Meal

Recruiting Locations

Lenexa Clinic
Lenexa, Kansas 66219

ICON Early Phase Services, LLC
San Antonio, Texas 78232

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.