Healthy ParticipantsPhase 1NCT05708573
Potential Drug Interaction Between ALXN2040 and Rosuvastatin
A Phase 1 study testing Rosuvastatin and ALXN2040 in people with Healthy Participants, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Rosuvastatin and ALXN2040
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 5 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Medically healthy participants with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory safety evaluation (hematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator.
- Body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive), with a minimum body weight of 50.0 kg at Screening.
Who cannot join
- History of any medical or psychiatric condition or disease that, in the opinion of the Investigator, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- History of meningococcal infection.
- History of drug or alcohol abuse within 2 years prior to first dose of study intervention, or positive drugs-of-abuse or alcohol screen at Screening or Day -1.
- Current tobacco users or smokers or a positive cotinine test at Screening.
- Any major surgery within 8 weeks of Screening.
- Donation of whole blood from 3 months prior to first dose, or of plasma from 30 days prior to first dose of study intervention.
Show all 10Show fewer
- History of malignancy within 5 years prior to Screening.
- Evidence of human immunodeficiency virus (HIV) infection (HIV antibody positive) at Screening.
- Evidence of hepatitis B (positive hepatitis B surface antigen or positive core antibody with negative surface antibody) or hepatitis C viral infection (hepatitis C virus antibody positive) at Screening.
- Female participant who is pregnant, breastfeeding, or intending to conceive during the course of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Potential Drug Interaction Between ALXN2040 and Rosuvastatin in Healthy Adult Participants
This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.
Read the 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
- Being tested
- Rosuvastatin, ALXN2040
- Keywords
- Drug-drug interaction, Breast cancer resistance protein, organic-anion transporting polyprotein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
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).
ALXN2040Drug
In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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. Receives: Drug: Rosuvastatin; Drug: ALXN2040 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma drug concentration during a dosing interval (Cmax) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours postdose
Area under the concentration-time curve from time zero to the time of the last observed/measured nonzero concentration (AUC0-last) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours postdose
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours postdose
Time to reach Cmax (tmax) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours postdose
First-order rate constant of drug associated with the terminal portion of the curve (λz) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours postdose
Percentage of AUC0-inf due to extrapolation from time of last quantifiable concentration to infinity (AUC%extrap) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours postdose
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours postdose
Apparent total plasma clearance after extravascular administration (CL/F) of rosuvastatin
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Up to 96 hours postdose
Cmax of ALXN2040
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
tmax of ALXN2040
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
Area under the concentration-time curve from time zero to 8 hours postdose (AUC0-8) of ALXN2040
To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
Measured: Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days]
Secondary outcomes (1)
Number of participants with adverse events (AEs)
To assess the safety and tolerability of multiple doses of ALXN2040 when co administered with a single dose of rosuvastatin.
Measured: 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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start1 Feb 2023
- Primary completion23 Mar 2023
- Study completion5 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708573
- Sponsor's protocol ID
- ALXN2040-HV-102
- Status last verified
- Apr 2023
- First submitted
- 23 Jan 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Potential Drug Interaction Between ALXN2040 and Rosuvastatin in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05708573
- Acronym / sponsor ID
- ALXN2040-HV-102
- Conditions
- Healthy Participants
- Keywords
- Drug-drug interaction, Breast cancer resistance protein, organic-anion transporting polyprotein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 5 Apr 2023 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Rosuvastatin, Drug: ALXN2040Participants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Medically healthy participants with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory safety evaluation (hematology, biochemistry, coagulation, and urinalysis) that is reasonably likely to interfere with participation in or ability to complete the study, or to potentially confound interpretation of study results, as assessed by the Investigator.
- Body mass index (BMI) within the range 18 to 32 kg/m^2 (inclusive), with a minimum body weight of 50.0 kg at Screening.
Key exclusion criteria (10 listed)
- History of any medical or psychiatric condition or disease that, in the opinion of the Investigator, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- History of meningococcal infection.
- History of drug or alcohol abuse within 2 years prior to first dose of study intervention, or positive drugs-of-abuse or alcohol screen at Screening or Day -1.
- Current tobacco users or smokers or a positive cotinine test at Screening.
- Any major surgery within 8 weeks of Screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RosuvastatinIn 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 | Cohort 1 |
| ALXN2040In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7. | Drug | Cohort 1 |
Primary outcome
Maximum observed plasma drug concentration during a dosing interval (Cmax) 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.
Area under the concentration-time curve from time zero to the time of the last observed/measured nonzero concentration (AUC0-last) 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.
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) 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 to reach Cmax (tmax) 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.
First-order rate constant of drug associated with the terminal portion of the curve (λz) 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.
Percentage of AUC0-inf due to extrapolation from time of last quantifiable concentration to infinity (AUC%extrap) 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.
Apparent volume of distribution during the terminal elimination phase after extravascular administration (Vd/F) 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.
Apparent total plasma clearance after extravascular administration (CL/F) 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.
Cmax of ALXN2040
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.
tmax of ALXN2040
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.
Area under the concentration-time curve from time zero to 8 hours postdose (AUC0-8) of ALXN2040
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.
1 secondary outcome
Number of participants with adverse events (AEs)
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]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rosuvastatin and ALXN2040 in people with Healthy Participants, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma drug concentration during a dosing interval (Cmax) of rosuvastatin (time frame: Up to 96 hours postdose). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2023.