A Study to Evaluate Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole & Carbamazepine in Healthy Adults

Last updated: June 17, 2024
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

ALXN2080

Fluconazole (AxMP)

Itraconazole

Clinical Study ID

NCT06173596
D7420C00003
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

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

Total Participants: 60
Treatment Group(s): 4
Primary Treatment: ALXN2080
Phase: 1
Study Start date:
January 10, 2024
Estimated Completion Date:
May 16, 2024

Connect with a study center

  • Research Site

    Ruddington, NG11 6JS
    United Kingdom

    Site Not Available

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