Healthy
Conditions
Keywords
ALXN2080, itraconazole, Fluconazole, carbamazepine
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 single dose PK of ALXN2080 (optional), and to determine the effect of multiple doses of carbamazepine on the single dose PK of ALXN2080.
Interventions
DRUGALXN2080
Participants will receive ALXN2080 orally.
DRUGItraconazole
Participants will receive Itraconazole orally.
DRUGFluconazole (AxMP)
Participants will receive Fluconazole orally.
DRUGCarbamazepine (AxMP)
Participants will receive Carbamazepine orally.
Sponsors
Alexion Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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. * 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 criteria
* 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ALXN2080 | Day 1 up to Day 24 |
| Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2080 | Day 1 up to Day 24 |
Secondary
| Measure | Time frame |
|---|---|
| Cmax of Fluconazole | Day 2 up to Day 5 |
| AUC(tau) of Fluconazole | Day 2 up to Day 5 |
| Cmax of Itraconazole | Day 4 up to Day 6 |
| AUC(tau) of Carbamazepine | Day 2 up to Day 20 |
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) | Baseline up to Day 34 |
| Cmax of Carbamazepine | Day 2 up to Day 20 |
| Area under the Curve for the Defined Interval Between Doses AUC(tau) of Itraconazole | Day 4 up to Day 6 |
Countries
United Kingdom
Outcome results
None listed