Potential Drug Interaction Between ALXN2040 and Rosuvastatin

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05708573
• Other study ID #: ALXN2040-HV-102
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: April 5, 2023

Study information

• Verified date: April 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 5, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Rosuvastatin
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).
• ALXN2040
In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7.

Locations

Country	Name	City	State
United States	Clinical Trial Site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Alexion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	First-order rate constant of drug associated with the terminal portion of the curve (?z) of rosuvastatin	To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.	Up to 96 hours postdose
Primary	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
Primary	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
Primary	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
Primary	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]
Primary	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]
Primary	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	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]