Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. | Up to 96 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Baltimore | Maryland | 21225 | United States |
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.
Not provided
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Not provided
| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ALXN2040 | Drug | In Treatment Period 2, participants will receive oral tablets of ALXN2040 three times daily on Days 1 through 7. |
|
| 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. |
| 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. | Up to 96 hours postdose |
| Cmax of ALXN2040 | To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin. | 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. | 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. | Treatment Period 2: Days 3 and 4 (Predose and Postdose) [Treatment period 2 is of 8 days] |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |