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NCT06160414 | COMPLETED | Healthy

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

Condition or disease

Healthy

Intervention/treatment

Metformin

Rosuvastatin

ALXN2080

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants
Actual Study Start Date : 2023-04-12
Estimated Primary Completion Date : 2024-02-05
Estimated Study Completion Date : 2024-02-05

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 55 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.
A Study to Investigate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants

Location Details

NCT06160414

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United Kingdom,

Research Site

Ruddington, United Kingdom, Ng11 6Js