A Study of the Cardiac Effects of ALXN1840 in Healthy Adults

• Status: Enrolling by invitation
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Collaborators: ERT: Clinical Trial Technology Solutions; PPD
• Treatments: Choline; Moxifloxacin; Tetrathiomolybdate

Criteria

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).