This Phase 1 study consists of two parts, all conducted in healthy volunteers (HVs). In Parts 1 and 2, the drug-drug interaction (DDI) potential of ALG-055009 will be explored, where subjects will be assigned to receive multiple doses of ALG-055009 and 2 single doses of one of the following concomitant drugs: atorvastatin (Part 1), or rosuvastatin (Part 2, optional).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
14
PPD Austin Research Unit
Austin, Texas, United States
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Time frame: 23 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Time frame: 23 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Time frame: 23 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Time frame: 23 days
C0 [predose]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Time frame: 23 days
Half-life [t1/2]
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Time frame: 23 days
Area under the concentration time curve [AUC]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: 22 days
Time to maximum plasma concentration [Tmax]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: 22 days
Maximum plasma concentration [Cmax]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
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Time frame: 22 days
Minimum plasma concentration [Cmin]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: 22 days
C0 [predose]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: 22 days
Half-life [t1/2]
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: 22 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: up to 23 days for part 1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1
Time frame: Up to 22 days for part 2
Time to maximum plasma concentration [Cmax] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Time frame: up to 23 days for part 1
Minimum plasma concentration [Cmin] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable
Time frame: up to 23 days for part 1
Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)PK
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Time frame: up to 23 days for part 1
Time to maximum plasma concentration [Tmax] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Time frame: up to 23 days for part 1
Half-life [t1/2] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Time frame: up to 23 days for part 1
Time to maximum plasma concentration [Cmax] of 2-hydroxy-atorvastatin (ng/mL)
Pharmacokinetic parameters of 2-hydroxy-atorvastatin and applicable
Time frame: up to 23 days for part 1
Minimum plasma concentration [Cmin] of 2-hydroxy-atorvastatin (ng/mL)
Pharmacokinetic parameters of 2-hydroxy-atorvastatin and applicable metabolites
Time frame: up to 23 days for part 1
Area under the concentration time curve [AUC] of 2-hydroxy-atorvastatin (ng/mL)
Pharmacokinetic parameters of atorvastatin and applicable metabolites
Time frame: up to 23 days for part 1
Time to maximum plasma concentration [Tmax] of 2-hydroxy-atorvastatin (ng/mL)
Pharmacokinetic parameters of 2-hydroxy-atorvastatin and applicable metabolites
Time frame: up to 23 days for part 1
Half-life [t1/2] of 2-hydroxy-atorvastatin (ng/mL)
Time to maximum plasma concentration \[Cmax\] of ALG-055009 (ng/mL)
Time frame: up to 23 days for part 1
Minimum plasma concentration [Cmin] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Time frame: up to 22 days for part 2
Area under the concentration time curve [AUC] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Time frame: up to 22 days for part 2
Time to maximum plasma concentration [Tmax] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Time frame: up to 22 days for part 2
Half-life [t1/2] of ALG-055009 (ng/mL)
Pharmacokinetic parameters of ALG-055009 and applicable metabolites
Time frame: up to 22 days for part 2
Time to maximum plasma concentration [Cmax] of rosuvastatin (ng/mL)
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: up to 22 days for part 2
Minimum plasma concentration [Cmin] of rosuvastatin (ng/mL)
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: up to 22 days for part 2
Area under the concentration time curve [AUC] of rosuvastatin (ng/mL)
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: up to 22 days for part 2
Time to maximum plasma concentration [Tmax] of rosuvastatin (ng/mL
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: up to 22 days for part 2
Half-life [t1/2] of rosuvastatin (ng/mL)
Pharmacokinetic parameters of rosuvastatin and applicable metabolites
Time frame: up to 22 days for part 2