NCT05780645

A Study to Investigate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants

A Two-Part Phase 1 Study to Evaluate the Pharmacokinetic Profile of ALXN2050 Modified Release Prototype Formulations and Immediate Release Reference Tablet in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (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 investigate the relative bioavailability and PK (Pharmacokinetic) profile of 2 ALXN2050 MR (Modified Release) formulations in comparison with the IR (Immediate Release) formulation.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	ALXN2050 MR Prototype Tablet	Participants will receive various doses of the MR Prototype Tablet orally.
DRUG	ALXN2050 Immediate Release (IR) Tablet	Participants will receive a single dose IR (ALXN2050 Film Coated Tablet) tablet orally.
DRUG	ALXN2050 MR Prototype Mini-Tablet	Participants will receive various doses of the MR Prototype Mini-Tablet orally.

Timeline

• Start date: 2023-03-15
• Primary completion: 2024-02-26
• Completion: 2024-02-26
• First posted: 2023-03-22
• Last updated: 2024-06-06

Locations

1 site across 1 country: United Kingdom