Phase 1
Completed N=57
A Study of the Cardiac Effects of ALXN1840 in Healthy Adults
Healthy
Source: ClinicalTrials.gov NCT04560816 ↗
Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: 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
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.
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 | — |
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).
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. Informational only — not medical advice.