The main purpose of this study is to learn more about the safety and side effects of LY3526318 when given by mouth to healthy participants. The study will have two parts. Each participant will enroll in only one part. For each participant, Part A will last up to 28 days and Part B will last up to 51 days, including screening and follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
76
PRA Health Sciences
Groningen, Netherlands
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
An SAE is any AE from this study that results in 1 of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e. immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect and important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent 1 of the other outcomes listed in the definition. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, are reported in the Adverse Events module section.
Time frame: Baseline Up To 32 Days
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3526318
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC\[0-∞\]) of LY3526318
Time frame: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 Hours (AUC[0-24]) of LY3526318
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to 24 hours (AUC\[0-24\]) of LY3526318
Time frame: MAD: Day 1: Predose,1, 2, 4, 6, 8 and 12 hours post dose
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Time frame: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Time frame: MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dose
PK: Time to Maximum Concentration (Tmax) of LY3526318
PK: Time to Maximum Concentration (Tmax) of LY3526318
Time frame: SAD: Day 1: predose, 1, 2, 4, 6, 8 and 12 hours postdose; Day 2 and Day 3: 24 and 48 hours postdose; 3-Period Food Effect Arms: Day 1: Predose, 1, 2, 4, 6, 8 and 12 hours, Day 2, Day 3 and Day 4: Predose, 24, 48 and 72 hours postdose
PK: Time to Maximum Concentration (Tmax) of LY3526318
PK: Time to Maximum Concentration (Tmax) of LY3526318
Time frame: MAD: Day 1 and Day 14: Predose, 1, 2, 4, 6, 8 and 12 hours post dose