This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.
This is a Phase 1, randomized, double-blind, placebo-controlled, sequential single/repeated-dose study. This study is a dose-escalation study with healthy participants in single ascending dose (SAD) including food-effect and multiple ascending dose (MAD) cohorts to determine the highest allowable dose (HAD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
The participants will receive a single oral dose of ID119031166M or once daily oral doses of ID119031166M for 14 days.
The participant will receive a oral dose of Placebo.
California Clinical trials medical group/PAREXEL
Glendale, California, United States
Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs)
To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants.
Time frame: From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)
Maximum plasma concentration determined directly from the concentration- time profile (Cmax)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants.
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized Cmax
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24)
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
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Time frame: Day 1-4 for SAD and Day 1-17 for MAD
Dose-normalized AUC0-last
To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants.
Time frame: Day 1-4 for SAD and Day 1-17 for MAD