NCT06173596

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN2080	Participants will receive ALXN2080 orally.
DRUG	Itraconazole	Participants will receive Itraconazole orally.
DRUG	Fluconazole (AxMP)	Participants will receive Fluconazole orally.
DRUG	Carbamazepine (AxMP)	Participants will receive Carbamazepine orally.

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-04-30
• Completion: 2024-05-16
• First posted: 2023-12-15
• Last updated: 2024-06-20

Locations

1 site across 1 country: United Kingdom