A Drug-Drug Interaction Study of ALXN2080 (QSC301430)
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Rosuvastatin and Metformin in Healthy Adult Participants
IRAS ID
1008636
Contact name
Andrew Ramsey
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, ALXN2080, as a potential treatment for complement alternative pathway (AP)-mediated disease. Complement forms part of the immune system and acts in various ways, such as via the alternative pathway, to protect from infection. This protective role is carefully controlled in healthy people, however, in AP-mediated diseases it is uncontrolled which leads to inflammation and damage.
This two-part study will assess how ALXN2080 interacts with two other licensed medicines; rosuvastatin (commonly used to treat high blood pressure) and metformin (commonly prescribed to patients with diabetes). In Part 1 we’ll give healthy volunteers single doses of rosuvastatin and metformin and in Part 2 we’ll give volunteers single doses of rosuvastatin and metformin, and multiple doses of the test medicine for up to 11 days.
In this study in healthy volunteers, we aim to answer these questions.
* Does taking the test medicine with metformin or rosuvastatin affect the blood levels of metformin or rosuvastatin?
* Does taking the test medicine with metformin or rosuvastatin cause any important side effects?
This study will take place at one non-NHS site in Nottingham.
We plan to enrol 20 healthy men and women aged 18-55 years, who will take part in both parts of the study.
Part 1: Each volunteer will receive up to one single dose of metformin and rosuvastatin, as tablets by mouth, without food.
Part 2: Volunteers will receive one single dose of metformin and rosuvastatin as tablets by mouth, and multiple doses of the test medicine, twice a day for up to 11 days, as capsules by mouth, without food.
In total across the two parts, volunteers will stay in the clinic for 25 nights, attend 1 outpatient visit, and take up to 8 weeks to finish the study.
We’ll collect blood and urine samples to:
* do safety tests
* measure the amount of metformin and rosuvastatin
* measure the amount of test medicine and its breakdown productsREC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
23/NW/0275
Date of REC Opinion
16 Nov 2023
REC opinion
Further Information Favourable Opinion