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

NCT05319899 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: WTX101-101CA12887
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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 Molybdenum.

Conditions

Healthy

Keywords

ALXN1840; WTX101; Omeprazole

Outcome Measures

Primary Outcomes (3)

• Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)

  AUC0-t was calculated by the linear trapezoidal method.

  Predose (0 hour) up to 192 hours postdose

• Maximum Measured Plasma Concentration (Cmax) of Total Mo

  Predose (0 hour) up to 192 hours postdose

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Day 1 through 14 days following final dose (up to Day 43)

Study Arms (6)

Sequence 1: ABC

EXPERIMENTAL

Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment B): 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 at Hour 0 on Day 1, 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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. There was a washout period of at least 14 days between each ALXN1840 dosing.

Drug: ALXN1840; Drug: Omeprazole

Sequence 2: ACB

EXPERIMENTAL

Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): 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 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.

Drug: ALXN1840; Drug: Omeprazole

Sequence 3: BAC

EXPERIMENTAL

Participants received each treatment on 1 occasion: Period 1 (Treatment B): 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 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. There was a washout period of at least 14 days between each ALXN1840 dosing.

Drug: ALXN1840; Drug: Omeprazole

Sequence 4: BCA

EXPERIMENTAL

Participants received each treatment on 1 occasion: Period 1 (Treatment B): 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 at Hour 0 on Day 1, 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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.

Drug: ALXN1840; Drug: Omeprazole

Sequence 5: CAB

EXPERIMENTAL

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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment B): 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 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.

Drug: ALXN1840; Drug: Omeprazole

Sequence 6: CBA

EXPERIMENTAL

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 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): 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 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.

Drug: ALXN1840; Drug: Omeprazole

Interventions

ALXN1840 DRUG

ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.

Also known as: WTX101 (formerly), Bis-choline tetrathiomolybdate, Tiomolibdate choline

Sequence 1: ABC; Sequence 2: ACB; Sequence 3: BAC; Sequence 4: BCA; Sequence 5: CAB; Sequence 6: CBA

Omeprazole DRUG

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.

Also known as: Prilosec

Sequence 1: ABC; Sequence 2: ACB; Sequence 3: BAC; Sequence 4: BCA; Sequence 5: CAB; Sequence 6: CBA

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

rhoA GTP-Binding Protein; tetrathiomolybdate; Omeprazole

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Alexion Pharmaceuticals Inc.
• Organization: Alexion Pharmaceuticals Inc.

clinicaltrials@alexion.com

+1 855-752-2356

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study.

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 8, 2022
• Study Start: January 20, 2014
• Primary Completion: March 24, 2014
• Study Completion: March 24, 2014
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2022-09

Locations

US (1)