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Part 2: Vemircopan and LNG/EE-Containing OCs for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body weight of at minimum 50 kg and body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive) at the Screening.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up period 2: days 4, 18 and 19
Awards & highlights

Study Summary

This trial will study how drugs interact with each other in healthy people.

Who is the study for?
This trial is for healthy individuals weighing at least 50 kg with a BMI of 18-32. Participants must use approved contraception methods and have no significant health issues as determined by medical exams, vital signs, ECGs, and lab tests.Check my eligibility
What is being tested?
The study examines how vemircopan interacts with metformin (diabetes medication), rosuvastatin (cholesterol-lowering drug), oral contraceptives containing levonorgestrel/ethinyl estradiol, and carbamazepine (seizure medication) in healthy people.See study design
What are the potential side effects?
Potential side effects may include those commonly associated with the drugs being tested: digestive issues from metformin; muscle pain or weakness from rosuvastatin; hormonal changes from oral contraceptives; dizziness or drowsiness from carbamazepine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I weigh at least 50 kg and my BMI is between 18 and 32.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~period 2: days 4, 18 and 19
This trial's timeline: 3 weeks for screening, Varies for treatment, and period 2: days 4, 18 and 19 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: AUC from time zero extrapolated to infinity (AUC∞) of Metformin
Part 1: AUC from time zero to the last quantifiable concentration (AUCt) of Metformin
Part 1: AUCt of Rosuvastatin
+12 more
Secondary outcome measures
Part 1: AUC during a dosing interval at steady state (AUCtau) of Vemircopan
Part 1: Apparent terminal elimination half-life (t½) of Metformin
Part 1: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Metformin
+37 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3: Vemircopan and CarbamazepineExperimental Treatment2 Interventions
Participants will receive Vemircopan and Carbemazepine in a fixed sequence over 2 periods. Period 1 (4 days): Participants will receive a single oral dose of vemircopan on day 1. Period 2 (22 days): Participants will receive carbemazepine twice daily from day 1 to day 21. On day 19, participants will receive a single oral dose of vemircopan co-administered with carbamazepine. There will be a washout period of at least 4 days between the dose of vemircopan in Period 1 and the first dose of carbamazepine in Period 2.
Group II: Part 2: Vemircopan and LNG/EE-Containing OCsExperimental Treatment2 Interventions
Participants will receive Vemircopan and LNG/EE-Containing OCs in a fixed sequence over 2 periods. Period 1 (7 days): Participants will receive a single dose of OC, consisting of LNG and EE on day 1. Period 2 (10 days): Participants will receive multiple doses of vemircopan from day 1 to day 9. On day 5, participants will receive a single dose of OC co-administered with vemircopan. There will be a washout period of at least 7 days between the dose of OC in Period 1 and the first dose of vemircopan in Period 2.
Group III: Part 1: Vemircopan, Metformin and RosuvastatinExperimental Treatment3 Interventions
Participants will receive Vemircopan, Metformin and Rosuvastatin in a fixed sequence over 2 periods. Period 1 (8 days): Participants will receive a single dose of metformin on day 1 and a single dose of rosuvastatin on day 4. Period 2 (12 days): Participants will receive vemircopan twice daily from day 1 to day 11. On day 5, participants will receive metformin co-administered with vemircopan. On day 8, participants will receive rosuvastatin co-administered with vemircopan. There will be a washout period of at least 4 days between the dose of rosuvastatin in Period 1 and the first dose of vemircopan in Period 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin
2019
Completed Phase 4
~3150
Metformin
2006
Completed Phase 4
~2430
Carbamazepine
2016
Completed Phase 4
~2690

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
41,122 Total Patients Enrolled
AlexionLead Sponsor
246 Previous Clinical Trials
39,217 Total Patients Enrolled

Frequently Asked Questions

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

Are there still places available for individuals to partake in this investigation?

"According to the data on clinicaltrials.gov, this medical study is currently open for recruitment and was initially posted in October of 2023 with a subsequent update in December that same year."

Answered by AI

Is eligibility for the trial restricted to people under 65 years of age?

"This experiment is open to individuals aged 18-55."

Answered by AI

How many individuals can participate in this trial at maximum?

"Indeed, clinicaltrials.gov confirms that this trial is currently recruiting volunteers. The original posting was released on October 9th 2023 and the most recent update occurred on December 7th 2023. A total of 60 participants are sought from one medical site."

Answered by AI

Has the FDA granted approval for Part 1: Vemircopan, Metformin and Rosuvastatin?

"Based on our team's assessment, the safety of Part 1: Vemircopan, Metformin and Rosuvastatin was rated a 1 because there is limited evidence to support its efficacy or safety in this Phase 1 clinical trial."

Answered by AI

Are there any restrictions for people who wish to participate in this clinical experiment?

"This clinical trial is open to 60 healthy individuals between 18-55 years old. Applicants must meet the following requirements: Medical history, physical or neurological examination, vital signs and 12 lead ECG all deemed safe by a medical professional; Body weight of at least 50 kg with BMI between 18-32kg/m^2 for both males and females; All participants should adhere to birth control methods as specified in the protocol."

Answered by AI

What is the predicted result of this medical study?

"According to Alexion Pharmaceuticals, Inc., the primary endpoint of this clinical trial is Area Under Curve (AUCt) of EE over 48 hours. Additionally, secondary endpoints include: predose concentration prior to morning dose (Ctrough) of Vemircopan; Cmax of Vemircopan; and Ctrough of Carbamazepine after multiple twice daily doses."

Answered by AI

Who else is applying?

What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine
2024. "Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06071442.
~40 spots leftby Apr 2025
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