Potential Drug Interaction Between ALXN2040 and Rosuvastatin

NCT05708573 | Completed Phase 1 FDA Drug

• 1 other identifier: ALXN2040-HV-102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

Drug-drug interaction; Breast cancer resistance protein; organic-anion transporting polyprotein

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (1)

• Number of participants with adverse events (AEs)

  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]

Study Arms (1)

Cohort 1

EXPERIMENTAL

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; Drug: ALXN2040

Interventions

Rosuvastatin 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).

Cohort 1

ALXN2040 DRUG

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

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

Baltimore, Maryland, 21225, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: February 1, 2023
• Primary Completion: March 23, 2023
• Study Completion: April 5, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (1)