A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT05319912
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1: ABC ALXN1840 Enteric-coated Tablet 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. Sequence 3: BAC ALXN1840 Enteric-coated Tablet 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. Sequence 1: ABC ALXN1840 Non-coated Capsule 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. Sequence 2: ACB ALXN1840 Enteric-coated Tablet 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. Sequence 2: ACB ALXN1840 Non-coated Capsule 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. Sequence 3: BAC ALXN1840 Non-coated Capsule 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. Sequence 4: BCA ALXN1840 Enteric-coated Tablet 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. Sequence 4: BCA ALXN1840 Non-coated Capsule 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. Sequence 5: CAB ALXN1840 Enteric-coated Tablet 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. Sequence 5: CAB ALXN1840 Non-coated Capsule 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. Sequence 6: CBA ALXN1840 Enteric-coated Tablet 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. Sequence 6: CBA ALXN1840 Non-coated Capsule 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. Sequence 6: CBA Omeprazole 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. Sequence 1: ABC Omeprazole 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. Sequence 2: ACB Omeprazole 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. Sequence 3: BAC Omeprazole 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. Sequence 4: BCA Omeprazole 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. Sequence 5: CAB Omeprazole 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.
- Primary Outcome Measures
Name Time Method Maximum Measured Plasma Concentration (Cmax) of Total Mo Predose (0 hour) up to 192 hours postdose Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo) Predose (0 hour) up to 192 hours postdose AUC0-t was calculated by the linear trapezoidal method.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Day 1 through 14 days following final dose (up to Day 43) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Trial Site
🇺🇸Lincoln, Nebraska, United States