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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06160414
• Other study ID #: D7420C00002
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2023
• Est. completion date: February 5, 2024

Study information

• Verified date: May 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 ALXN2080 on the single-dose PK of rosuvastatin and to determine the effect of multiple doses of ALXN2080 on the single-dose PK of metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 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.

• 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Metformin
Participants will receive Metformin orally, after fasting.
• Rosuvastatin
Participants will receive Rosuvastatin orally, after fasting.
• ALXN2080
Participants will receive ALXN2080 orally, after fasting.

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 Rosuvastatin		Day 3 up to Day 12
Primary	Area Under the Plasma Concentration Versus Time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin		Day 3 up to Day 12
Primary	Cmax of Metformin		Day 1 up to Day 9
Primary	AUC0-inf of Metformin		Day 1 up to Day 9
Secondary	Number of Participants with Treatment-emergent Adverse Events (TEAEs)		Baseline up to Day 29
Secondary	Cmax of ALXN2080		Day 1 up to Day 18
Secondary	Area Under the Plasma Concentration Versus Time Curve for the Defined Interval Between Doses AUC(tau) of ALXN2080		Day 1 up to Day 18