A Study to Investigate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants

Study Overview
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Brief Summary
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The primary objectives of this study are to determine the effect of multiple doses of ALXN2080 on the single-dose PK of rosuvastatin and to determine the effect of multiple doses of ALXN2080 on the single-dose PK of metformin.

Official Title
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A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: Metformin
* Drug: Rosuvastatin
* Drug: ALXN2080


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or non-pregnant, non-lactating healthy females. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, triplicate 12-lead ECG, screening clinical laboratory profiles (hematology, clinical chemistry, coagulation, and urinalysis), as deemed by the Investigator or designee. Body Mass Index (BMI) within the range of 18.0 to 32.0 kg/m2 (inclusive) and a minimum body weight of 50.0 kg at screening. Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance. Exclusion Criteria: History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological or other disorders. History of meningococcal infection. History of additional risk factors for Torsades de Pointes (eg, heart failure, hypokalemia, family history of Long QT syndrome). History of clinically significant hypersensitivity or idiosyncratic reaction to the study intervention or related compounds. History of unexplained, recurrent infection, or infection requiring treatment with systemic antibiotics within 14 days prior to Period 1 Day 1. History of significant multiple and/or severe allergies (hay fever is allowed unless it is active), including significant hypersensitivity reactions to commonly used antibacterial agents, including beta-lactams, penicillin, amoxicillin, aminopenicillin, fluoroquinolones (specifically including ciprofloxacin), cephalosporins, and carbapenems, which in the opinion of the Investigator would make it difficult to provide empiric antibiotic therapy or treat an active infection. Diseases or conditions or previous procedures known to interfere with the absorption, distribution, metabolism, or excretion of drugs. History of malignancy within 5 years prior to screening, with the exception of nonmelanoma skin cancer or carcinoma in situ of the cervix that has been treated with no evidence of recurrence. Known hepatic or biliary abnormalities (including participants with Gilberts syndrome). Participants with a history of cholecystectomy or gall stones.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>On Day 1, all participants will receive a single oral dose (fasted) of Metformin followed by a single oral dose (fasted) of Rosuvastatin on Day 3. | Drug: Metformin<br>* Participants will receive Metformin orally, after fasting.<br>Drug: Rosuvastatin<br>* Participants will receive Rosuvastatin orally, after fasting.<br>|
| Experimental: Cohort 2<br>All participants will receive ALXN2080 twice daily (BID) on Day 1 to Day 11. On the morning of Day 6, participants will be given a single dose of Metformin co-administered with the morning dose of ALXN2080. On the morning of Day 8, participants will be given a single dose of Rosuvastatin co-administered with the morning dose of ALXN2080. | Drug: Metformin<br>* Participants will receive Metformin orally, after fasting.<br>Drug: Rosuvastatin<br>* Participants will receive Rosuvastatin orally, after fasting.<br>Drug: ALXN2080<br>* Participants will receive ALXN2080 orally, after fasting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin |  | Day 3 up to Day 12 | 
| Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin |  | Day 3 up to Day 12 | 
| Cmax of Metformin |  | Day 1 up to Day 9 | 
| AUC0-inf of Metformin |  | Day 1 up to Day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) |  | Baseline up to Day 29 | 
| Cmax of ALXN2080 |  | Day 1 up to Day 18 | 
| Area Under the Plasma Concentration Versus Time Curve for the Defined Interval Between Doses AUC(tau) of ALXN2080 |  | Day 1 up to Day 18 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosuvastatin, ALXN2080, metformin