Clinical trial NCT05708573: Potential Drug Interaction Between ALXN2040 and Rosuvastatin
Official title: A Phase 1 Study to Evaluate the Potential Drug Interaction Between ALXN2040 and Rosuvastatin in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Drug-drug interaction
Breast cancer resistance protein
organic-anion transporting polyprotein
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum observed plasma drug concentration during a dosing interval (Cmax) of rosuvastatin
timeFrame: Up to 96 hours postdose
measure: Area under the concentration-time curve from time zero to the time of the last observed/measured nonzero concentration (AUC0-last) of rosuvastatin
timeFrame: Up to 96 hours postdose
measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of rosuvastatin
timeFrame: Up to 96 hours postdose
measure: Time to reach Cmax (tmax) of rosuvastatin
timeFrame: Up to 96 hours postdose
measure: First-order rate constant of drug associated with the terminal portion of the curve (λz) of rosuvastatin
timeFrame: Up to 96 hours postdose
measure: Percentage of AUC0-inf due to extrapolation from time of last quantifiable concentration to infinity (AUC%extrap) of rosuvastatin
timeFrame: Up to 96 hours postdose
measure: Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F) of rosuvastatin
timeFrame: Up to 96 hours postdose
measure: Apparent total plasma clearance after extravascular administration (CL/F) of rosuvastatin
timeFrame: Up to 96 hours postdose
measure: Cmax of ALXN2040
timeFrame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
measure: tmax of ALXN2040
timeFrame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
measure: Area under the concentration-time curve from time zero to 8 hours postdose (AUC0-8) of ALXN2040
timeFrame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: 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]
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Clinical Trial Site
state: Maryland
Study officials:
References: