A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults

Sponsor

Alexion Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT05319912

Collaborator

(none)

Enrollment

Location

Arms

1.7

Actual Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Mo concentration.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ALXN1840 Enteric-coated Tablet Drug: ALXN1840 Non-coated Capsule Drug: Omeprazole	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

A Phase 1, Single-Center, Randomized, 3-Period Crossover Study in Healthy Volunteers to Evaluate the Absorption of WTX101 After Single Dose Administration of an Enteric Coated Formulation With and Without Food and a Non-Coated Formulation Coadministered With a Proton Pump Inhibitor Without Food

Actual Study Start Date :

Apr 7, 2014

Actual Primary Completion Date :

May 29, 2014

Actual Study Completion Date :

May 29, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1: ABC Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 tablets following an overnight fast. Period 2 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. There was a washout period of at least 14 days between each ALXN1840 dosing.	Drug: ALXN1840 Enteric-coated Tablet ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: ALXN1840 Non-coated Capsule ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: Omeprazole Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1. Other Names: Prilosec
Experimental: Sequence 2: ACB Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 tablets following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. Period 3 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.	Drug: ALXN1840 Enteric-coated Tablet ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: ALXN1840 Non-coated Capsule ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: Omeprazole Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1. Other Names: Prilosec
Experimental: Sequence 3: BAC Participants received each treatment on 1 occasion: Period 1 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment A): ALXN1840 tablets following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. There was a washout period of at least 14 days between each ALXN1840 dosing.	Drug: ALXN1840 Enteric-coated Tablet ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: ALXN1840 Non-coated Capsule ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: Omeprazole Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1. Other Names: Prilosec
Experimental: Sequence 4: BCA Participants received each treatment on 1 occasion: Period 1 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. Period 3 (Treatment A): ALXN1840 tablets following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.	Drug: ALXN1840 Enteric-coated Tablet ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: ALXN1840 Non-coated Capsule ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: Omeprazole Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1. Other Names: Prilosec
Experimental: Sequence 5: CAB Participants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. Period 2 (Treatment A): ALXN1840 tablets following an overnight fast. Period 3 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.	Drug: ALXN1840 Enteric-coated Tablet ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: ALXN1840 Non-coated Capsule ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: Omeprazole Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1. Other Names: Prilosec
Experimental: Sequence 6: CBA Participants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 non-coated capsules at Hour 0 on Day 1. Period 2 (Treatment B): ALXN1840 tablets after the start of a high-fat breakfast, preceded by an overnight fast. Period 3 (Treatment A): ALXN1840 tablets following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.	Drug: ALXN1840 Enteric-coated Tablet ALXN1840 (60 milligrams) was administered orally as EC tablets at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: ALXN1840 Non-coated Capsule ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1. Other Names: WTX101 (formerly) Bis-choline tetrathiomolybdate Tiomolibdate choline Drug: Omeprazole Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1. Other Names: Prilosec

Outcome Measures

Primary Outcome Measures

Area Under The Concentration Versus Time Curve To The Last Measurable Concentration (AUC0-t) Of Total Molybdenum [Up to 192 hours postdose]
Maximum Measured Plasma Concentration (Cmax) Of Total Molybdenum [Up to 192 hours postdose]
Count Of Participants Experiencing Treatment-emergent Adverse Events [Day 1 through 14 days (±2 days) following final dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Non-smoker
Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms.
Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
Willing and able to adhere to contraception requirements.

Exclusion Criteria:

Participant was mentally or legally incapacitated
History or presence of clinically significant medical or psychiatric condition or disease.
History of any illness that might have interfered with drug absorption.
History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
History or presence of alcoholism or drug abuse.
Female participants who were pregnant or lactating.
Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
Serum ceruloplasmin and copper values outside of the normal range at screening.
On a diet incompatible with the on-study diet within the 28 days prior to the first ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat breakfast.
Participation in a previous clinical trial with ALXN1840.