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

NCT06160414 | Completed Phase 1

• 1 other identifier: D7420C00002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

rosuvastatin; ALXN2080; metformin

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

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; Drug: Rosuvastatin

Cohort 2

EXPERIMENTAL

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; Drug: Rosuvastatin; Drug: ALXN2080

Interventions

Metformin DRUG

Participants will receive Metformin orally, after fasting.

Cohort 1; Cohort 2

Rosuvastatin DRUG

Participants will receive Rosuvastatin orally, after fasting.

Cohort 1; Cohort 2

ALXN2080 DRUG

Participants will receive ALXN2080 orally, after fasting.

Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Research Site

Ruddington, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

Metformin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: April 12, 2023
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

GB (1)