The main purpose of this study is to learn more about how the drug is absorbed in to the blood stream and how it is eliminated from the body. The safety and tolerability of LY3526318 will also be evaluated when given by mouth either by single or multiple doses 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 44 days and Part B will last up to 50 days, including screening and follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
16
PRA Health Sciences
Groningen, Netherlands
Part A - SAD, Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞) of LY3526318
Time frame: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose
Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Part A - SAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Time frame: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose
Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC[0-tau ]) of LY3526318
Part B - MAD, PK: Area Under the Concentration Time Curve From Time Zero to the End of the Dosing Interval, Tau (AUC\[0-tau \]) of LY3526318
Time frame: Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose
Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Part B - MAD, PK: Maximum Observed Drug Concentration (Cmax) of LY3526318
Time frame: Day 5: Predose,1, 2, 4, 6, 8,12, 24 hours post dose
Part A, SAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Time frame: Single oral dose to up to 11 days of follow-up
Part B, MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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A TEAE started on or after the date and time of the first dose of study drug administered in this study, or started prior to the study drug administration but worsened after the study drug started. Clinically significant events were defined as SAEs and other non-serious adverse events (AEs). A summary of SAEs and other non-serious AEs is located in the Reported Adverse Events module.
Time frame: Up to 14 days following first dose
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Maximum Concentration (Cmax)
Part A, Effect of a meal on pharmacokinetics of LY3526318: Maximum Concentration (Cmax)
Time frame: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC 0-∞)
Part A, Effect of a meal on pharmacokinetics of LY3526318: Area under the concentration time curve from time 0 to infinity (AUC 0-∞)
Time frame: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)
Part A, Effect of a Meal on Pharmacokinetics of LY3526318: Time at Maximal Concentration (Tmax)
Time frame: Predose,1, 2, 4, 6, 8,12, 24, 48, 72, 96 hours post-dose