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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06173596
• Other study ID #: D7420C00003
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2024
• Est. completion date: May 16, 2024

Study information

• Verified date: June 2024
• Source: Alexion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 16, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN2080
Participants will receive ALXN2080 orally.
• Itraconazole
Participants will receive Itraconazole orally.
• Fluconazole (AxMP)
Participants will receive Fluconazole orally.
• Carbamazepine (AxMP)
Participants will receive Carbamazepine orally.

Locations

Country	Name	City	State
United Kingdom	Research Site	Ruddington

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of ALXN2080		Day 1 up to Day 24
Primary	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	Cmax of Itraconazole		Day 4 up to Day 6
Secondary	Area under the Curve for the Defined Interval Between Doses AUC(tau) of Itraconazole		Day 4 up to Day 6
Secondary	Cmax of Fluconazole		Day 2 up to Day 5
Secondary	AUC(tau) of Fluconazole		Day 2 up to Day 5
Secondary	Cmax of Carbamazepine		Day 2 up to Day 20
Secondary	AUC(tau) of Carbamazepine		Day 2 up to Day 20
Secondary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Baseline up to Day 34