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Completed

NCT Number: NCT04660890

A Study of the Cardiac Effects of ALXN2050 in Healthy Adults

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Tempe, Arizona, 85283, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
  • No clinically significant history or presence of ECG abnormalities at screening.
  • Female participants must be of non-childbearing potential and need not employ a method of contraception.
  • Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.

Exclusion criteria

  • Clinically significant laboratory abnormalities.
  • History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
  • History or presence of drug or alcohol abuse within previous 2 years, current tobacco and/or nicotine user, or positive alcohol and/or drug screen at screening or Day -1 of Period 1.
  • History or presence of clinically significant seizures, head injury, or head trauma.
  • History of procedures that could alter absorption or excretion of orally administered drugs.
  • History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
  • History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
  • Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
  • Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.
  • Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.

Treatment and study plan

ALXN2050

Drug

ALXN2050 will be administered orally twice daily as powder-in-capsule.

Other names: ACH-0145228 (formerly)

ALXN2050-matching Placebo

Drug

ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.

moxifloxacin

Drug

Moxifloxacin will be administered as a single oral dose.

Moxifloxacin-matching placebo

Drug

Moxifloxacin-matching placebo will be administered as a single oral dose.

Primary outcomes

  1. Placebo-corrected Change From Baseline QTc Intervals (ddQTc) For ALXN2050

    Time frame: Pre-dose through 24 hours post-dose

    Twelve-lead electrocardiograms (ECGs) will be extracted from continuous (Holter) recordings.

Secondary outcomes

  1. Change From Baseline PR Interval (dPR) For ALXN2050

    Time frame: Pre-dose through 24 hours post-dose

    Twelve-lead ECGs will be extracted from continuous (Holter) recordings.

  2. ddQTc For Moxifloxacin

    Time frame: Pre-dose through 24 hours post-dose

    Twelve-lead ECGs will be extracted from continuous (Holter) recordings.

  3. Area Under The Plasma Concentration-time Curve During A Dosing Interval (tau) At Steady-state (AUCtau) For ALXN2050

    Time frame: Pre-dose through 24 hours post-dose

  4. Maximum Observed Plasma Concentration Following Multiple Dosing (Cmax,ss) For ALXN2050

    Time frame: Up to 24 hours postdose

  5. Time To Maximum Observed Plasma Concentration Following Multiple Dosing (Tmax,ss) For ALXN2050

    Time frame: Pre-dose through 24 hours post-dose

  6. Incidence Of Treatment-emergent Adverse Events

    Time frame: Day 1 (postdose) through follow-up (7 [+/- 2] days after last study drug administration)

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Collaborators

  • Celerion

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 9, 2020
Registry last updated
Dec 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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