Clinical trial NCT04610580: Bioavailability Study of 2 Oral Formulations of ALXN1840
Official title: A Phase 1, Randomized, 2-period, 2-sequence, Crossover With Parallel-group Extension, Open-label Study to Compare the Relative Bioavailability of 2 Oral Formulations of ALXN1840 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioavailability
Healthy
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-30
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a 2-period, 2-sequence, crossover study with a parallel group extension.
Primary purpose: TREATMENT

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

Detailed description: This is a two-way crossover study consisting of 2 dosing periods assessing a test and reference formulation of ALXN1840. A dose-proportionality parallel group design extension period will be conducted following completion of the two-way crossover period of the study and will assess 5 different ascending doses of ALXN1840. There will be at least a 14-day washout following doses between Periods 1 and 2 and also at least a 14-day washout following the dose in Period 2 and the following dose in the Dose-Proportionality Extension Period.

Safety will be assessed throughout the study.

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 \<32 kg/meter squared for all participants
* Willing and able to follow protocol-specified contraception requirements

Exclusion Criteria:

* History or presence of clinical and/or laboratory disorders
* Abnormal blood pressure, defined as supine blood pressure ≤90/60 millimeters of mercury (mmHg) or \>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

Primary outcomes:
measure: Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)
timeFrame: predose (0.5 hour) and up to 336 hours postdose
measure: Two-way Crossover Period: Cmax for PUF Mo
timeFrame: predose (0.5 hour) and up to 336 hours postdose
measure: 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
timeFrame: predose (0.5 hour) and up to 336 hours postdose
measure: Two-way Crossover Period: AUCt for Plasma PUF Mo
timeFrame: predose (0.5 hour) and up to 336 hours postdose
measure: Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo
timeFrame: predose (0.5 hour) and up to 336 hours postdose
Secondary outcomes:
measure: Dose-Proportionality Extension Period: Cmax For Plasma Total Mo
timeFrame: predose (0.5 hour) and up to 336 hours postdose
measure: Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo
timeFrame: predose (0.5 hour) and up to 336 hours postdose
measure: Dose-Proportionality Extension Period: AUCt For Plasma Total Mo
timeFrame: predose (0.5 hour) and up to 336 hours postdose
measure: Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo
timeFrame: predose (0.5 hour) and up to 336 hours postdose
measure: Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo
timeFrame: predose (0.5 hour) and up to 336 hours postdose
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Pty Ltd.
state: Victoria
Study officials:
affiliation: Alexion Pharmaceuticals, Inc.
name: Eugene S. Swenson, MD, PhD
role: STUDY_DIRECTOR
affiliation: Alexion Pharmaceuticals, Inc.
name: Masood Sadaat, MD, MSc
role: STUDY_CHAIR
References: