Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ALXN1840

Study type: Interventional

Funder types: Industry

Identifiers

NCT05303324

2019-000516-28 (EudraCT Number)

ALXN1840-HV-104

Details and patient eligibility

About

To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
• Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
• Willing to adhere to contraception requirements.
• Satisfactory medical assessment with no clinically significant or relevant abnormalities.

Exclusion criteria

• Current or recurrent/chronic disease
• Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
• Acute or chronic hepatitis C virus infection.
• History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
• Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
• Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
• Serum ceruloplasmin value outside of the normal range at Screening
• Female participants who were breastfeeding.
• Prior exposure to ALXN1840.
• Major surgery or hospitalization within 90 days prior to dosing on Day 1.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Sequence 1 (AB)

Experimental group

Description:

Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows: Period 1: ALXN1840 as a single EC tablet (Treatment A, reference). Period 2: ALXN1840 as three EC tablets (Treatment B, test). Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement. There was a washout period of at least 14 days between each ALXN1840 dosing.

Treatment:

Drug: ALXN1840

Sequence 2 (BA)

Experimental group

Description:

Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows: Period 1: ALXN1840 as three EC tablets (Treatment B, test). Period 2: ALXN1840 as a single EC tablet (Treatment A, reference). Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement. There was a washout period of at least 14 days between each ALXN1840 dosing.

Treatment:

Drug: ALXN1840