Phase I Drug-Drug interaction study with ALXN2080 (QSC301589)
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole, and Carbamazepine in Healthy Adult Participants
IRAS ID
1008600
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 diseases. Complement forms part of the immune system and acts in various ways, such as via the AP to protect from infection. This is uncontrolled in AP mediated diseases leading to inflammation and damage.
This 3-part study will assess how ALXN2080 interacts with 3 licenced medicines; itraconazole (used to treat fungal infections), fluconazole (used to treat fungal infections) and carbamazepine (used to manage and treat epilepsy, trigeminal neuralgia, and acute manic and mixed episodes in bipolar 1 disorder).
In this study we aim to assess whether taking the test medicine with itraconazole, fluconazole or carbamazepine affects the blood levels of the test medicine, or causes any important side effects.
This study will take place at 1 non-NHS site in Nottingham. Volunteers will only take part in 1 part of the study. We plan to enrol 20 healthy men and women aged 18-55 years in each part.
Part 1: Volunteers will receive up to 2 single doses of test medicine on 2 occasions and 13 single doses of itraconazole, over 13 consecutive days, as capsules by mouth, without food. They’ll stay in the clinic for 20 nights and take up to 8 weeks to finish the study.
Part 2: Volunteers will receive up to 2 single doses of test medicine on 2 occasions and 10 single doses of fluconazole, over 10 consecutive days, as capsules by mouth, without food. They’ll stay in the clinic for 17 nights and take up to 8 weeks to finish the study.
Part 3: Volunteers will receive up to 2 single doses of test medicine on 2 occasions and 46 single doses of carbamazepine, over 23 consecutive days, as capsules and tablets by mouth, without food. They’ll stay in the clinic for 32 nights and take up to 10 weeks to finish the study.
We’ll collect blood and urine samples to:
*do safety tests
*measure the amount of licenced medicine, test medicine and its breakdown productsREC name
North East - York Research Ethics Committee
REC reference
23/NE/0187
Date of REC Opinion
24 Nov 2023
REC opinion
Further Information Favourable Opinion