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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Metformin; Drug: Rosuvastatin; Drug: ALXN2080

• Registration Number: NCT06160414
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-12
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Study First Posted: 2023-12-07
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort 2	ALXN2080	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.
Cohort 1	Metformin	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.
Cohort 1	Rosuvastatin	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.
Cohort 2	Rosuvastatin	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.
Cohort 2	Metformin	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Baseline up to Day 29

Trial Locations

Locations (1)

Research Site; 🇬🇧 Ruddington, United Kingdom