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A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

NCT04560816 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2023-08-14

Study results available
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Summary

This study will evaluate the effect of a supratherapeutic dose of ALXN1840 on the heart rate (HR)-corrected QT interval (QTc) in healthy adult participants. Moxifloxacin will be used as the active control.

Conditions

  • Healthy

Interventions

DRUG

ALXN1840

ALXN1840 (120 milligrams) will be administered orally (supratherapeutic dose).

DRUG

Placebo

Placebo will be administered orally.

DRUG

Moxifloxacin

Moxifloxacin (400 milligrams) will be administered orally.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • ERT: Clinical Trial Technology Solutions

    collaborator OTHER

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Eugene S. Swenson, MD, PhD · Alexion Pharmaceuticals, Inc.

  • Masood Sadaat, MD, MSc · Alexion Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2021-03-24
Completion
2021-03-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04560816 on ClinicalTrials.gov