This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.
This is an open-label, 2-treatment, 2-period, fixed-sequence DDI study in healthy adult participants. This study will comprise of: * Screening duration of 27 days. * Two treatment periods: Approximately 14 days. Treatment Period 1: 6 days Treatment Period 2: 8 days * Follow-up: 7 (± 2) days following the final dose of study intervention. There will be a washout period of at least 5 days between the single dose of rosuvastatin in Treatment Period 1 and the first dose of ALXN2040 in Treatment Period 2. Each participant will be involved in the study for approximately 48 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
In Treatment Period 1, participants will receive a single oral tablet of rosuvastatin in the morning of Day 1. In treatment period 2, on the morning of Day 4, participants will receive a single 20 mg dose of rosuvastatin (co-administered with the morning dose of ALXN2040).
In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7.
Clinical Trial Site
Baltimore, Maryland, United States
Maximum observed plasma drug concentration during a dosing interval (Cmax) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
Area under the concentration-time curve from time zero to the time of the last observed/measured nonzero concentration (AUC0-last) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
Time to reach Cmax (tmax) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
First-order rate constant of drug associated with the terminal portion of the curve (λz) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
Percentage of AUC0-inf due to extrapolation from time of last quantifiable concentration to infinity (AUC%extrap) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F) of rosuvastatin
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To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
Apparent total plasma clearance after extravascular administration (CL/F) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
Cmax of ALXN2040
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
tmax of ALXN2040
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
Area under the concentration-time curve from time zero to 8 hours postdose (AUC0-8) of ALXN2040
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
Number of participants with adverse events (AEs)
To assess the safety and tolerability of multiple doses of ALXN2040 when co administered with a single dose of rosuvastatin.
Time frame: Screening (Day -28 to -2) Up to Follow-up Visit (7 ± 2 days after the last dose of study intervention, or at early discontinuation from the study) [approximately 48 days]