A Study of Food Effect on Tersolisib (LY4064809) in Healthy Participants
Recruiting
Phase 1Interventional Study
Healthy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Basic Science
Participants needed
60 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 …
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.
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.