Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults

Sponsor

Alexion Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT05303324

Collaborator

(none)

Enrollment

Location

Arms

3.2

Actual Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ALXN1840	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Randomized, Open-Label, 2-Way Crossover Study to Assess the Single-Dose Pharmacokinetics of ALXN1840 Enteric-Coated Tablets at 2 Dose Strengths in Healthy Adult Subjects

Actual Study Start Date :

Jul 4, 2019

Actual Primary Completion Date :

Oct 9, 2019

Actual Study Completion Date :

Oct 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 (AB) 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.	Drug: ALXN1840 Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period. Other Names: Bis-choline Tetrathiomolybdate Tiomolibdic Acid WTX101 (formerly)
Experimental: Sequence 2 (BA) 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.	Drug: ALXN1840 Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period. Other Names: Bis-choline Tetrathiomolybdate Tiomolibdic Acid WTX101 (formerly)

Arm

Intervention/Treatment

Experimental: Sequence 1 (AB)

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.

Drug: ALXN1840

Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.

Other Names:

Bis-choline Tetrathiomolybdate

Tiomolibdic Acid

WTX101 (formerly)

Experimental: Sequence 2 (BA)

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.

Drug: ALXN1840

Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.

Other Names:

Bis-choline Tetrathiomolybdate

Tiomolibdic Acid

WTX101 (formerly)

Outcome Measures

Primary Outcome Measures

Maximum Observed (Plasma) Concentration (Cmax) Of Total Molybdenum [Up to 240 hours postdose]
Area Under The Concentration Versus Time Curve From Time 0 (Dosing) To The Last Quantifiable Concentration (AUCt) Of Total Molybdenum [Up to 240 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.