Phase 1
Completed N=18
A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults
Healthy
Source: ClinicalTrials.gov NCT05319912 ↗
Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo) — 16026; 5740; 19809 hours*ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo) |
16026; 5740; 19809 | — |
| PRIMARY Maximum Measured Plasma Concentration (Cmax) of Total Mo |
376; 187; 442 | — |
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
4; 2; 6 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05319912). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.