A Study of the Cardiac Effects of ALXN2050 in Healthy Adults

NCT04660890 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ALXN2050-HV-107
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

ALXN2050; Electrocardiogram; QT Interval; Concentration-QT; Factor D Inhibitor

Outcome Measures

Primary Outcomes (1)

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

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

  Pre-dose through 24 hours post-dose

Secondary Outcomes (6)

• Change From Baseline PR Interval (dPR) For ALXN2050

  Pre-dose through 24 hours post-dose

• ddQTc For Moxifloxacin

  Pre-dose through 24 hours post-dose

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

  Pre-dose through 24 hours post-dose

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

  Up to 24 hours postdose

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

  Pre-dose through 24 hours post-dose

Study Arms (3)

Treatment Arm (ABC)

EXPERIMENTAL

Treatment Sequence ABC - Participants will receive all 3 doses of ALXN2050 in a multiple-ascending fashion over 3 periods: Treatment A (Period 1): ALXN2050 Dose 120 milligrams (mg) and moxifloxacin-matching placebo. Treatment B (Period 2): ALXN2050 Dose 240 mg and moxifloxacin-matching placebo. Treatment C (Period 3): ALXN2050 Dose 360 mg and moxifloxacin-matching placebo.

Drug: ALXN2050; Drug: Moxifloxacin-matching Placebo

Control Arm (DEF)

PLACEBO COMPARATOR

Treatment Sequence DEF - Participants will receive ALXN2050-matching placebo over 3 periods: Treatment D (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. Treatment E (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin. Treatment F (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.

Drug: ALXN2050-matching Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin-matching Placebo

Control Arm (GHI)

PLACEBO COMPARATOR

Treatment Sequence GHI - Participants will receive ALXN2050-matching placebo over 3 periods: Treatment G (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin. Treatment H (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin-matching placebo. Treatment I (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin.

Drug: ALXN2050-matching Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin-matching Placebo

Interventions

ALXN2050 DRUG

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

Also known as: ACH-0145228 (formerly)

Treatment Arm (ABC)

ALXN2050-matching Placebo DRUG

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

Control Arm (DEF); Control Arm (GHI)

Moxifloxacin DRUG

Moxifloxacin will be administered as a single oral dose.

Control Arm (DEF); Control Arm (GHI)

Moxifloxacin-matching Placebo DRUG

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

Control Arm (DEF); Control Arm (GHI); Treatment Arm (ABC)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Celerion: collaborator

Study Sites (1)

Clinical Trial Site

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Interventions

rhoA GTP-Binding Protein; Moxifloxacin

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 9, 2020
• Study Start: December 12, 2020
• Primary Completion: March 16, 2021
• Study Completion: March 16, 2021
• Last Updated: December 29, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)