Clinical Trial Site
Baltimore, Maryland, 21225, United States
NCT Number: NCT05708573
This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21225, United States
This is an open-label, 2-treatment, 2-period, fixed-sequence DDI study in healthy adult participants.
This study will comprise of:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7.
Time frame: Up to 96 hours postdose
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Up to 96 hours postdose
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Time frame: 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]
To assess the safety and tolerability of multiple doses of ALXN2040 when co administered with a single dose of rosuvastatin.
Alexion Pharmaceuticals, Inc.
Industry
A Phase 1 Study to Evaluate the Potential Drug Interaction Between ALXN2040 and Rosuvastatin in Healthy Adult Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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