Phase
Condition
N/ATreatment
ALXN2080
Fluconazole (AxMP)
Itraconazole
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy males or non-pregnant, non-lactating healthy females.
Participants who are overtly healthy as determined by medical evaluation includingmedical 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.
Female participants of childbearing potential and male participants must followprotocol-specified contraception guidance
BMI within the range of 18.0 to 32.0 kg/m2 (inclusive) and a minimum body weight of 50.0 kg at screening.
Exclusion
Exclusion Criteria:
History of clinically significant cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrinological, hematological, neurological, psychiatric orother disorders; constituting a risk when taking the study intervention; orinterfering with the interpretation of data.
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 unexplained, recurrent infection, or infection requiring treatment withsystemic antibiotics within 14 days prior to Period 1 Day 1.
History of significant multiple and/or severe allergies (hay fever is allowed unlessit is active), including significant hypersensitivity reactions to commonly usedantibacterial agents, including beta-lactams, penicillin, amoxicillin,aminopenicillin, fluoroquinolones (specifically including ciprofloxacin),cephalosporins, and carbapenems, which in the opinion of the Investigator would makeit difficult to provide empiric antibiotic therapy or treat an active infection.
Diseases or conditions or previous procedures known to interfere with theabsorption, distribution, metabolism, or excretion of drugs.
History of malignancy within 5 years prior to screening, with the exception ofnonmelanoma skin cancer or carcinoma in situ of the cervix that has been treatedwith no evidence of recurrence.
Known hepatic or biliary abnormalities (including participants with Gilbert'ssyndrome).
Study Design
Connect with a study center
Research Site
Ruddington, NG11 6JS
United KingdomSite Not Available
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