Phase 1 N=57 Randomized Double-blind Treatment

A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT04560816 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis — -0.21; -0.31; 0.07; -0.64 ms

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: ALXN1840 (Drug); Placebo (Drug); Moxifloxacin (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Alexion Pharmaceuticals, Inc.
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis	-0.21; -0.31; 0.07; -0.64; -1.08; -0.90	—
SECONDARY ΔΔQTcF For Moxifloxacin Using The By-time Point Analysis	9.65; 11.04; 11.37	—
SECONDARY Change From Baseline For Heart Rate (ΔHR)	-0.27; 0.50; 1.27; -0.02; 0.38; 3.87	—
SECONDARY Change From Baseline QT Interval Using Fridericia's Formula (ΔQTcF)	-2.56; -2.36; 2.29; -0.49; -0.19; 9.47	—
SECONDARY Change From Baseline PR Interval (ΔPR)	-0.13; 1.26; -1.33; 0.41; 1.66; -1.37	—
SECONDARY Change From Baseline QRS Interval (ΔQRS)	-0.01; -0.07; -0.08; 0.04; -0.04; 0.06	—
SECONDARY Placebo-corrected Change From Baseline Heart Rate (ΔΔHR)	-0.77; 0.77; -0.40; 3.50; -0.31; 1.78	—
SECONDARY Placebo-corrected Change From Baseline PR Interval (ΔΔPR)	-1.39; -2.60; -1.25; -3.03; -0.24; -2.31	—
SECONDARY Placebo-corrected Change From Baseline QRS Interval (ΔΔQRS)	0.07; -0.01; 0.08; 0.10; 0.17; -0.01	—
SECONDARY Number of Participants With Treatment-emergent T-wave Morphology Abnormalities and U-waves	0; 0; 1; 0; 0; 0	—
SECONDARY ALXN1840 PK Parameter: Area Under The Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUC0-t) Of Total Molybdenum And Plasma Ultrafiltrate (PUF) Molybdenum Following a Single Oral Dose of ALXN1840	18450; 1763	—
SECONDARY ALXN1840 PK Parameter: Maximum Observed Concentration (Cmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840	504.1; 127.9	—
SECONDARY ALXN1840 PK Parameter: Time To Maximum Observed Concentration (Tmax) Of Total Molybdenum And PUF Molybdenum Following a Single Oral Dose of ALXN1840	5.00; 6.00	—
SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	9; 3; 6; 0; 0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Nonsmoker.
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.
Willing and able to follow protocol-specified contraception requirements.
Participant has no clinically significant history or presence of ECG findings.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04560816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.