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CompletedNCT06160414Updated Apr 24, 2025

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

A Phase 1 interventional study of Metformin and Rosuvastatin in Healthy, sponsored by Alexion Pharmaceuticals, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-24.

Sponsored by Alexion Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Apr 2023, registered Nov 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • rosuvastatin
  • ALXN2080
  • metformin
03

In context

Lead sponsor

Alexion Pharmaceuticals, Inc. is the lead sponsor of 249 studies on the registry; 25 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 70 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Cohort 1

    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

  • Experimental
    Cohort 2

    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

  • DrugMetformin

    Participants will receive Metformin orally, after fasting.

  • DrugRosuvastatin

    Participants will receive Rosuvastatin orally, after fasting.

  • DrugALXN2080

    Participants will receive ALXN2080 orally, after fasting.

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin

    Time frame: Day 3 up to Day 12

  2. Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin

    Time frame: Day 3 up to Day 12

  3. Cmax of Metformin

    Time frame: Day 1 up to Day 9

  4. AUC0-inf of Metformin

    Time frame: Day 1 up to Day 9

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline up to Day 29

  2. Cmax of ALXN2080

    Time frame: Day 1 up to Day 18

  3. Area Under the Plasma Concentration Versus Time Curve for the Defined Interval Between Doses AUC(tau) of ALXN2080

    Time frame: Day 1 up to Day 18

07

Study locations

1 site
  • Research Site
    Ruddington, NG11 6JS, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06160414
Lead sponsor
Alexion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Dec 7, 2023
Start date
Apr 12, 2023
Primary completion
Feb 5, 2024
Completion
Feb 5, 2024
Last update
Apr 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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