NCT05708573

Potential Drug Interaction Between ALXN2040 and Rosuvastatin

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

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

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-03-23
• Completion: 2023-04-05
• First posted: 2023-02-01
• Last updated: 2023-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study