Phase 1 N=48 Randomized Treatment

Bioavailability Study of 2 Oral Formulations of ALXN1840

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT04610580 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo) — 227.0186; 238.2725 nanograms (ng)/milliliter (mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: ALXN1840 (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Alexion Pharmaceuticals, Inc.
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)	227.0186; 238.2725	—
PRIMARY Two-way Crossover Period: Cmax for PUF Mo	11.758; 12.120	—
PRIMARY Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) For Plasma Total Mo	8654.3114; 9253.7266	—
PRIMARY Two-way Crossover Period: AUCt for Plasma PUF Mo	766.7655; 811.7275	—
PRIMARY Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo	10149.7531; 10068.8862	—
SECONDARY Dose-Proportionality Extension Period: Cmax For Plasma Total Mo	41.0441; 104.4313; 199.4759; 396.0000	—
SECONDARY Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo	8.505; 9.341; 16.557; 25.945	—
SECONDARY Dose-Proportionality Extension Period: AUCt For Plasma Total Mo	1677.8616; 4053.6004; 7439.1004; 16778.1770	—
SECONDARY Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo	584.5782; 826.2629; 805.6937; 976.4214	—
SECONDARY Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo	4920.5103; 9057.1367; 17842.1736	—

Summary

The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.

Eligibility Criteria

Inclusion Criteria

No clinically significant history or presence of electrocardiogram findings
Body weight ≥50 to ≤100 kilograms (kg) and body mass index 18 to 140/90 mmHg
Lymphoma, leukemia, or any malignancy within the past 5 years
Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit of normal
Serum copper or serum ceruloplasmin below lower limit of normal
Hemoglobin <130 grams (g)/liter (L) for males and hemoglobin <115 g/L for females
Significant allergies
Smoker

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04610580). 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.