A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04560816

Run by

Alexion Pharmaceuticals, Inc.

People needed

57

Starts

2020-07-24

Expected to finish

2021-03-24

Last updated by the study team

2023-08-14

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• PPD Development, LP — Austin, Texas, United States

Full record on ClinicalTrials.gov

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