The primary purpose of this study is to assess the safety and tolerability of AG-181 in healthy participants after oral administration of single ascending dose (SAD) of AG-181 in Part 1 and multiple ascending dose (MAD) in Part 2 along with the effect of food on the pharmacokinetics (PK) of single oral doses of AG-181 in healthy participants in Part 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
ICON 1255 East 3900 South
Salt Lake City, Utah, United States
SAD: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug
Time frame: Up to Day 7
MAD: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug
Time frame: Up to Day 26
Food Effect: Maximum Observed Plasma Concentration (Cmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Area Under the Concentration-time Curve up to the Last Quantifiable Concentration (AUC0-last) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Terminal Elimination Rate Constant (Kel) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Terminal Elimination Half-Life (t1/2) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Apparent Oral Clearance (CL/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
Food Effect: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
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Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Maximum Observed Plasma Concentration (Cmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Terminal Elimination Rate Constant (Kel) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Terminal Elimination Half-Life (t1/2) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Area Under the Concentration-time Curves (AUCs) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Apparent Oral Clearance (CL/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 4
SAD: Renal Clearance (CLR) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Total Percent of AG-181 Dose Excreted Unchanged in Urine (Fet%)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Percent of AG-181 Dose Excreted Unchanged in Urine Between Time 1 and Time 2 (Fet1-t2%)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Cumulative Amount of AG-181 Drug Excreted in Urine (Ae0-t)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
SAD: Amount of AG-181 Drug Excreted in Urine Between Time 1 and Time 2 (Aet1-t2)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
MAD: Maximum Observed Plasma Concentration (Cmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Time to Reach Maximum Observed Concentration (tmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Terminal Elimination Rate Constant (Kel) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Terminal Elimination Half-Life (t1/2) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Area Under the Concentration-time Curve (AUC) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Apparent Oral Clearance (CL/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Apparent Volume of Distribution at Terminal Phase (Vz/F) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Time to Maximum Observed Plasma Concentration at Steady State (Cmax_ss) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 17
MAD: Accumulation Ratio for Cmax (RA_Cmax) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 14
MAD: Accumulation Ratio for Area Under the Concentration-time Curve (RA_AUC) of AG-181
Time frame: Predose and multiple time points postdose from Day 1 to Day 14
Food Effect: Number of Participants with AEs and SAEs by Type, Severity, and Relationship to Study Drug
Time frame: Up to Day 7