CompletedPhase 1

A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

United States57 participantsStarted 2020-07-24

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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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 \<90/50 millimeters of mercury (mm Hg) or \>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).

What they're measuring

Placebo-corrected Change From Baseline For QTcF (ΔΔQTcF) for ALXN1840 Using The By-time Point Analysis

Timeframe: Baseline (average of samples taken at -45, -30, and -15 minutes before dosing), 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 (Day 2) hours postdose

Trial details

NCT IDNCT04560816

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-24

Results submitted2022-03-25

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