Clinical trial · Interventional
Potential Drug Interaction Between ALXN2040 and Rosuvastatin
A Phase 1 Study to Evaluate the Potential Drug Interaction Between ALXN2040 and Rosuvastatin in Healthy Adult Participants
NCT05708573CI-TRIAL-00065663completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will assess the potential drug-drug interaction (DDI) between ALXN2040 and rosuvastatin.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Healthy Participants | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALXN2040 | Drug | — | UNRESOLVED |
| Rosuvastatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- 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.
- interventionNames
- Drug: Rosuvastatin
- Drug: ALXN2040
Primary outcomes (11)
- measure
- Maximum observed plasma drug concentration during a dosing interval (Cmax) of rosuvastatin
- timeFrame
- Up to 96 hours postdose
- description
- To determine the effect of multiple doses of ALXN2040 on the single-dose PK of rosuvastatin.
- measure
- Area under the concentration-time curve from time zero to the time of the last observed/measured nonzero concentration (AUC0-last) of rosuvastatin
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.