Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Date last updated
16/01/2024

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
The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.
Trial website
https://clinicaltrials.gov/study/NCT04610580
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04610580