Potential Drug Interaction Between ALXN2040 and Rosuvastatin

Study Overview
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Brief Summary
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This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.

Detailed Description
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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.

Official Title
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A Phase 1 Study to Evaluate the Potential Drug Interaction Between ALXN2040 and Rosuvastatin in Healthy Adult Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: ALXN2040


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically healthy participants with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory safety evaluation (hematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator. Body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive), with a minimum body weight of 50.0 kg at Screening. Exclusion Criteria: History of any medical or psychiatric condition or disease that, in the opinion of the Investigator, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study. History of meningococcal infection. History of drug or alcohol abuse within 2 years prior to first dose of study intervention, or positive drugs-of-abuse or alcohol screen at Screening or Day -1. Current tobacco users or smokers or a positive cotinine test at Screening. Any major surgery within 8 weeks of Screening. Donation of whole blood from 3 months prior to first dose, or of plasma from 30 days prior to first dose of study intervention. History of malignancy within 5 years prior to Screening. Evidence of human immunodeficiency virus (HIV) infection (HIV antibody positive) at Screening. Evidence of hepatitis B (positive hepatitis B surface antigen or positive core antibody with negative surface antibody) or hepatitis C viral infection (hepatitis C virus antibody positive) at Screening. Female participant who is pregnant, breastfeeding, or intending to conceive during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Participants will receive a single dose of rosuvastatin in the morning of Day 1 in Treatment Period 1. Following a washout period of 5 days, participants will receive ALXN2040 three times daily on Days 1 through 7 in treatment period 2. | Drug: Rosuvastatin<br>* 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).<br>Drug: ALXN2040<br>* In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Up to 96 hours postdose | 
| Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F) of rosuvastatin | To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin. | 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. | Up to 96 hours postdose | 
| Cmax of ALXN2040 | To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin. | 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. | 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. | Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-drug interaction, Breast cancer resistance protein, organic-anion transporting polyprotein