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OpenTrials
Completed

NCT Number: NCT06160414

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Ruddington, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

Participants will receive Metformin orally, after fasting.

Rosuvastatin

Drug

Participants will receive Rosuvastatin orally, after fasting.

ALXN2080

Drug

Participants will receive ALXN2080 orally, after fasting.

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

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2023
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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