A Study to Investigate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants

Study identifier:D7420C00002

ClinicalTrials.gov identifier:NCT06160414

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Metformin, Rosuvastatin, ALXN2080

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 07 Dec 2023

Primary Completion Date: 05 Feb 2024

Study Completion Date: 05 Feb 2024

Study design

Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 May 2024 by Alexion Pharmaceuticals, Inc.

Collaborators

Inclusion and exclusion criteria

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.
- Body Mass Index (BMI) within the range of 18.0 to 32.0 kg/m2 (inclusive) and a minimum body weight of 50.0 kg at screening.
- Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.

Exclusion Criteria

- History of clinically significant cardiovascular, respiratory, hepatic, renal,
gastrointestinal, endocrinological, hematological, neurological or other disorders.
- 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 clinically significant hypersensitivity or idiosyncratic reaction to the study intervention or related compounds.
- 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 Gilberts syndrome).
- Participants with a history of cholecystectomy or gall stones.

No locations available

Arms	Assigned Interventions
Experimental: Cohort 1 On Day 1, all participants will receive a single oral dose (fasted) of Metformin followed by a single oral dose (fasted) of Rosuvastatin on Day 3.	Drug: Metformin Participants will receive Metformin orally, after fasting. Drug: Rosuvastatin Participants will receive Rosuvastatin orally, after fasting.
Experimental: Cohort 2 All participants will receive ALXN2080 twice daily (BID) on Day 1 to Day 11. On the morning of Day 6, participants will be given a single dose of Metformin co-administered with the morning dose of ALXN2080. On the morning of Day 8, participants will be given a single dose of Rosuvastatin co-administered with the morning dose of ALXN2080.	Drug: Metformin Participants will receive Metformin orally, after fasting. Drug: Rosuvastatin Participants will receive Rosuvastatin orally, after fasting. Drug: ALXN2080 Participants will receive ALXN2080 orally, after fasting.

Contacts

Contact

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356

[email protected]