A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: ALXN1840; Drug: Moxifloxacin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04560816

ALXN1840-HV-107

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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57 participants in 6 patient groups

Treatment Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: ALXN1840

Drug: Moxifloxacin

Treatment Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: ALXN1840

Drug: Moxifloxacin

Treatment Sequence 3

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: ALXN1840

Drug: Moxifloxacin

Treatment Sequence 4

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: ALXN1840

Drug: Moxifloxacin

Treatment Sequence 5

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: ALXN1840

Drug: Moxifloxacin

Treatment Sequence 6

Experimental group

Description:

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.

Treatment:

Drug: Placebo

Drug: ALXN1840

Drug: Moxifloxacin