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Completed

NCT Number: NCT06173596

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Ruddington, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ALXN2080

Drug

Participants will receive ALXN2080 orally.

Itraconazole

Drug

Participants will receive Itraconazole orally.

Fluconazole (AxMP)

Drug

Participants will receive Fluconazole orally.

Carbamazepine (AxMP)

Drug

Participants will receive Carbamazepine orally.

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of ALXN2080

    Time frame: Day 1 up to Day 24

  2. Area Under the Curve From Time 0 to the Time of Last Measurable Concentration (AUC0-last) of ALXN2080

    Time frame: Day 1 up to Day 24

Secondary outcomes

  1. Cmax of Itraconazole

    Time frame: Day 4 up to Day 6

  2. Area under the Curve for the Defined Interval Between Doses AUC(tau) of Itraconazole

    Time frame: Day 4 up to Day 6

  3. Cmax of Fluconazole

    Time frame: Day 2 up to Day 5

  4. AUC(tau) of Fluconazole

    Time frame: Day 2 up to Day 5

  5. Cmax of Carbamazepine

    Time frame: Day 2 up to Day 20

  6. AUC(tau) of Carbamazepine

    Time frame: Day 2 up to Day 20

  7. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline up to Day 34

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole, and Carbamazepine in Healthy Adult Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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