Potential Drug Interaction Between ALXN2040 and Rosuvastatin

NCT ID: NCT05708573

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-04-05

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.

Conditions

Healthy Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

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.

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

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).

Intervention Type: DRUG

ALXN2040

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

ALXN2040-HV-102

Identifier Type: -

Identifier Source: org_study_id