A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-24

Study Completion Date

2021-03-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of the Cardiac Effects of ALXN2050 in Healthy Adults

NCT04660890

Healthy

COMPLETED PHASE1

Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects

NCT00434395

Healthy

COMPLETED PHASE1

A Study of the Cardiac Effects of Danicopan in Healthy Adults

NCT05016206

Healthy

COMPLETED PHASE1

A Thorough QT Study of TR-701free Acid (FA) in Healthy Subjects

NCT01461460

Healthy Volunteer

COMPLETED PHASE1

A Study to Define the ECG Effects of Lixivaptan Compared to Placebo and Moxifloxacin in Healthy Adult Men and Women: A Thorough ECG Study

NCT00675701

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a randomized, 3-treatment, 3-period, 6-sequence, crossover, placebo- and active-controlled, double-blind for ALXN1840, open-label for moxifloxacin, in healthy adult participants. Participants will be domiciled in the clinic for 7 days during Treatment Period 1 and for 6 days during Treatment Period 2 and 3. A single oral dose of each treatment (ALXN1840, matching ALXN1840 placebo, or moxifloxacin) will be administered on Day 1 of each period following an overnight fast of at least 10 hours. There will be a minimum 14-day washout between study intervention administrations for each treatment period. Cardiodynamic, pharmacokinetic, and safety assessments will be performed at certain times during the study. An end-of-study visit will occur 14 days (±2 days) after the last dose.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This will be a 3-treatment, 3-period, 6-sequence, crossover study in healthy adults.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

This study will employ a double-blind study design. The ALXN1840 and matching placebo will be identical in appearance and will be administered in a double-blind manner.

Moxifloxacin will not be blinded.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Sequence 1

On Day 1 of each period, participants will receive a single dose of the following study interventions:

Period 1: ALXN1840.

Period 2: Placebo-matching ALXN1840.

Period 3: Moxifloxacin.

Group Type EXPERIMENTAL

ALXN1840

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type DRUG

Moxifloxacin (400 milligrams) will be administered orally.

Treatment Sequence 2

On Day 1 of each period, participants will receive a single dose of the following study interventions:

Period 1: ALXN1840.

Period 2: Moxifloxacin.

Period 3: Placebo-matching ALXN1840.

Group Type EXPERIMENTAL

ALXN1840

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type DRUG

Moxifloxacin (400 milligrams) will be administered orally.

Treatment Sequence 3

On Day 1 of each period, participants will receive a single dose of the following study interventions:

Period 1: Placebo-matching ALXN1840.

Period 2: ALXN1840.

Period 3: Moxifloxacin.

Group Type EXPERIMENTAL

ALXN1840

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type DRUG

Moxifloxacin (400 milligrams) will be administered orally.

Treatment Sequence 4

On Day 1 of each period, participants will receive a single dose of the following study interventions:

Period 1: Placebo-matching ALXN1840.

Period 2: Moxifloxacin.

Period 3: ALXN1840.

Group Type EXPERIMENTAL

ALXN1840

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type DRUG

Moxifloxacin (400 milligrams) will be administered orally.

Treatment Sequence 5

On Day 1 of each period, participants will receive a single dose of the following study interventions:

Period 1: Moxifloxacin.

Period 2: ALXN1840.

Period 3: Placebo-matching ALXN1840.

Group Type EXPERIMENTAL

ALXN1840

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type DRUG

Moxifloxacin (400 milligrams) will be administered orally.

Treatment Sequence 6

On Day 1 of each period, participants will receive a single dose of the following study interventions:

Period 1: Moxifloxacin.

Period 2: Placebo-matching ALXN1840.

Period 3: ALXN1840.

Group Type EXPERIMENTAL

ALXN1840

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo will be administered orally.

Moxifloxacin

Intervention Type DRUG

Moxifloxacin (400 milligrams) will be administered orally.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ALXN1840

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

Intervention Type DRUG

Placebo

Placebo will be administered orally.

Intervention Type DRUG

Moxifloxacin

Moxifloxacin (400 milligrams) will be administered orally.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

WTX101 Bis-choline tetrathiomolybdate Tiomolibdate choline Placebo-matching ALXN1840

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Nonsmoker.
2. Body weight at least 60 kilograms (kg) for males or 52 kg for females and body mass index ≥18.0 and ≤30.0 kg/meter squared.
3. Willing and able to follow protocol-specified contraception requirements.
4. Participant has no clinically significant history or presence of ECG findings.

Exclusion Criteria

1. History or presence of clinical and/or lab disorders.
2. Lymphoma, leukemia, or any malignancy within the past 5 years, or breast cancer within the past 10 years.
3. Participant has abnormal blood pressure, defined as a supine blood pressure \<90/50 millimeters of mercury (mm Hg) or \>140/90 mm Hg.
4. Serum potassium, calcium, or magnesium levels outside the normal range.
5. Serum copper and/or ceruloplasmin values below the lower limit of normal at Screening.
6. Female participant has hemoglobin \<10.8 grams/deciliter (g/dL) and male participant has hemoglobin \<12.5 g/dL.
7. Clinically significant multiple or severe allergies.
8. Alanine aminotransferase, aspartate aminotransferase, serum creatinine, or total bilirubin greater than upper limit of normal (with the exception of Gilbert's syndrome).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes