The aim of this multi-part Phase 1 study is to evaluate the drug-drug interaction (DDI) potential of ALG-097558 via co-administration with a P-gp substrate (dabigatran) and a CYP3A4 inhibitor/P-gp inhibitor (itraconazole). In addition, this study will evaluate the relative bioavailability and food effect of a new tablet formulation for ALG-097558. This study consists of 3 parts, all conducted in healthy volunteers (HV). Study Parts A and B are designed to assess the perpetrator or victim DDI risk of ALG-097558 mediated by CYP/P-gp interactions in healthy adult subjects. Part A will evaluate the potential impact of itraconazole, a CYP3A potent inhibitor, while Part B will investigate the potential impact of ALG-097558 (perpetrator) on dabigatran etexilate, a P-gp transporter substrate. Study Part C is designed to study the bioavailability of a new formulation of the ALG-097558 tablet and the food effect on this tablet. This study has one primary objective for each part of the study. For Part A: to evaluate the effect of a CYP3A4 inhibitor/Pg-p inhibitor, itraconazole, on the pharmacokinetics (PK) of ALG-097558 and the metabolite, ALG-097730. For Part B: to evaluate the effect of multiple doses of ALG-097558 on the pharmacokinetics of a P-gp substrate, dabigatran. For Part C: to evaluate the relative bioavailability of 2 different tablet formulations of ALG-097558 and effect of food on the pharmacokinetics of ALG-097558 and the metabolite, ALG-097730.
Age range
18 Years – 65 Years
Sex
ALL
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Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf): ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Elimination Half-life (t1/2):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Maximum Observed Concentration (Cmax):ALG-097558 in Plasma in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Time of Observed Maximum Concentration (Tmax):ALG-097558 in Part A and Part C, Dabigatran (Total) in Plasma in Part B
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part B-0 to 72 hours post dose on Days 1 to 8 Part C-0 to 72 hours post dose on Days 1 to 9
Area Under the Concentration-time Curve From Time Zero to Infinity [Extrapolated] (AUC0-inf) for ALG-097730 Plasma in Part A and Part C
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Area Under the Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUClast) for ALG-097730 in Plasma in Part A and Part C
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Elimination Half-life (t1/2) for ALG-097730 in Plasma in Part A and Part C
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Maximum Observed Concentration (Cmax) for ALG-097730 in Plasma in Part A and Part C
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9
Time of Observed Maximum Concentration (Tmax) for ALG-097730 in Part A and Part C
Timeframe: Part A-0 to 72 hours post dose on Days 1 to 10 Part C-0 to 72 hours post dose on Days 1 to 9