Phase 1
Completed N=48
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
Healthy
Source: ClinicalTrials.gov NCT05303324 ↗
Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum — 173.10; 174.27 nanograms (ng)/milliliter (mL)
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum |
173.10; 174.27 | — |
| PRIMARY Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt) of Total Molybdenum |
7054.5; 6990.5 | — |
| SECONDARY Number of Participants With a Treatment-Emergent Adverse Event (TEAEs) |
7; 5; 4; 8; 0; 0 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05303324). 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.