NCT04610580

Bioavailability Study of 2 Oral Formulations of ALXN1840

A Phase 1, Randomized, 2-period, 2-sequence, Crossover With Parallel-group Extension, Open-label Study to Compare the Relative Bioavailability of 2 Oral Formulations of ALXN1840 in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.

Detailed description

This is a two-way crossover study consisting of 2 dosing periods assessing a test and reference formulation of ALXN1840. A dose-proportionality parallel group design extension period will be conducted following completion of the two-way crossover period of the study and will assess 5 different ascending doses of ALXN1840. There will be at least a 14-day washout following doses between Periods 1 and 2 and also at least a 14-day washout following the dose in Period 2 and the following dose in the Dose-Proportionality Extension Period. Safety will be assessed throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN1840	ALXN1840 will be administered orally.

Timeline

• Start date: 2021-01-31
• Primary completion: 2021-03-24
• Completion: 2021-04-26
• First posted: 2020-10-30
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study