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Unknown
Cohort 1 for Healthy Subjects
Phase 1
Waitlist Available
Research Sponsored by Alexion Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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]
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how two drugs interact with each other to see if they are safe to take together.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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]
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Apparent total plasma clearance after extravascular administration (CL/F) of rosuvastatin
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F) of rosuvastatin
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of rosuvastatin
+8 moreSecondary study objectives
Number of participants with adverse events (AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Cohort 1Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
2019
Completed Phase 4
~3150
ALXN2040
2023
Completed Phase 1
~20
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
36,695 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
38,609 Total Patients Enrolled
Alexion Pharmaceuticals, Inc.Lead Sponsor
259 Previous Clinical Trials
140,416 Total Patients Enrolled
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