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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04610580




Registration number
NCT04610580
Ethics application status
Date submitted
13/10/2020
Date registered
30/10/2020

Titles & IDs
Public title
Bioavailability Study of 2 Oral Formulations of ALXN1840
Scientific 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
Secondary ID [1] 0 0
ALXN1840-HV-109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ALXN1840

Experimental: Crossover ALXN1840 Sequence 1 - Participants will first receive a single dose of ALXN1840 test formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 reference formulation on Day 1 of Period 2.

Experimental: Crossover ALXN1840 Sequence 2 - Participants will first receive a single dose of ALXN1840 reference formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 test formulation on Day 1 of Period 2.

Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 1 - Participants will receive a single dose of ALXN1840.

Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 2 - Participants will receive a single dose of ALXN1840.

Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 3 - Participants will receive a single dose of ALXN1840.

Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 4 - Participants will receive a single dose of ALXN1840.


Treatment: Drugs: ALXN1840
ALXN1840 will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)
Timepoint [1] 0 0
predose (0.5 hour) and up to 336 hours postdose
Primary outcome [2] 0 0
Two-way Crossover Period: Cmax for PUF Mo
Timepoint [2] 0 0
predose (0.5 hour) and up to 336 hours postdose
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
predose (0.5 hour) and up to 336 hours postdose
Primary outcome [4] 0 0
Two-way Crossover Period: AUCt for Plasma PUF Mo
Timepoint [4] 0 0
predose (0.5 hour) and up to 336 hours postdose
Primary outcome [5] 0 0
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo
Timepoint [5] 0 0
predose (0.5 hour) and up to 336 hours postdose
Secondary outcome [1] 0 0
Dose-Proportionality Extension Period: Cmax For Plasma Total Mo
Timepoint [1] 0 0
predose (0.5 hour) and up to 336 hours postdose
Secondary outcome [2] 0 0
Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo
Timepoint [2] 0 0
predose (0.5 hour) and up to 336 hours postdose
Secondary outcome [3] 0 0
Dose-Proportionality Extension Period: AUCt For Plasma Total Mo
Timepoint [3] 0 0
predose (0.5 hour) and up to 336 hours postdose
Secondary outcome [4] 0 0
Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo
Timepoint [4] 0 0
predose (0.5 hour) and up to 336 hours postdose
Secondary outcome [5] 0 0
Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo
Timepoint [5] 0 0
predose (0.5 hour) and up to 336 hours postdose

Eligibility
Key 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/04/2021
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Eugene S. Swenson, MD, PhD
Address 0 0
Alexion Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04610580