NCT04660890

A Study of the Cardiac Effects of ALXN2050 in Healthy Adults

A Multiple-Ascending-Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled Study to Evaluate the Effect of ALXN2050 on the QT Interval in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.

Detailed description

Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ALXN2050	ALXN2050 will be administered orally twice daily as powder-in-capsule.
DRUG	ALXN2050-matching Placebo	ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.
DRUG	Moxifloxacin	Moxifloxacin will be administered as a single oral dose.
DRUG	Moxifloxacin-matching Placebo	Moxifloxacin-matching placebo will be administered as a single oral dose.

Timeline

• Start date: 2020-12-12
• Primary completion: 2021-03-16
• Completion: 2021-03-16
• First posted: 2020-12-09
• Last updated: 2021-12-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study