Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

Phase 1

Completed

Brief Summary: 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).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Sequence 2 (BA)	ALXN1840	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.
Sequence 1 (AB)	ALXN1840	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.

Primary Outcome Measures

Name	Time	Method
Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum	Up to 240 hours postdose	The pharmacokinetic (PK) data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via inductively coupled plasma-mass spectroscopy (ICP-MS).
Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt) of Total Molybdenum	Up to 240 hours postdose	The PK data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via ICP-MS.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Treatment-Emergent Adverse Event (TEAEs)	Baseline up to Day 43	An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was an AE that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. A related TEAE was defined as having a reasonable possibility the study intervention caused the AE as assessed by the investigator. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.