Status:
COMPLETED
A Study to Evaluate Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole & Carbamazepine in Healthy Adults
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The primary objectives of this study are to determine the effect of multiple doses of itraconazole on the single dose PK of ALXN2080, to determine the effect of multiple doses of fluconazole on the si...
Eligibility Criteria
Inclusion
- 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.
- Female participants of childbearing potential and male participants must follow protocol-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
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, psychiatric or other disorders; constituting a risk when taking the study intervention; or interfering 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 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 Gilbert's syndrome).
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 16 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06173596
Start Date
January 10 2024
End Date
May 16 2024
Last Update
June 20 2024
Active Locations (1)
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1
Research Site
Ruddington, United Kingdom, NG11 6JS