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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

Study 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]

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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] for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

Number of participants with adverse events (AEs)

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

Do I qualify?Apply below to find out

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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

37,403 Total Patients Enrolled

AlexionLead Sponsor

246 Previous Clinical Trials

39,257 Total Patients Enrolled

Alexion Pharmaceuticals, Inc.Lead Sponsor

252 Previous Clinical Trials

41,132 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participating in this trial greater than fifty years?

"According to the requirements, potential participants must be 18 years of age or older but not exceed 55."

Answered by AI

Has Cohort 1 earned regulatory approval from the FDA?

"Our assessment at Power of Cohort 1's safety was a score of 1, as it is currently undergoing Phase I trials. This implies that only preliminary data exists to attest its efficacy and security profile."

Answered by AI

Are there still opportunities for individuals to partake in this research?

"Clinicaltrials.gov confirms that this clinical trial is still open to participants, having been posted on February 1st 2023 and updated as recently as February 10th 2023."

Answered by AI

How many individuals are engaged in this investigation?

"Affirmative. Data hosted on clinicaltrials.gov affirms that this medical experiment, initially posted February 1st 2023, is presently enrolling participants. Around 20 patients are required to be sourced from a single medical site."

Answered by AI

Could I qualify for this clinical trial's enrollment criteria?

"This clinical trial is recruiting 20 participants between the ages of 18 and 55 who have no underlying medical issues. The enrollees must also meet body mass index parameters in a range from 18 to 32 kg/m^2 (inclusive) and possess an initial weight that surpasses 50 kilograms. Furthermore, these potential patients should pass physical exams as well as 12-lead electrocardiograms (ECG), hematology tests, biochemistry assessments, coagulation examinations, and urinalysis evaluations with flying colors prior to being accepted into the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Potential Drug Interaction Between ALXN2040 and Rosuvastatin

2023. "Potential Drug Interaction Between ALXN2040 and Rosuvastatin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05708573.