HealthyPhase 1NCT04610580

Bioavailability Study of 2 Oral Formulations of ALXN1840

A Phase 1 study testing ALXN1840 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ALXN1840
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteAustralia
Study dates: 31 Jan 2021to 26 Apr 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

Nucleus Network Pty Ltd.
Melbourne, Victoria, 3004

Other trials in Australia

About this study

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

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

Read the 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.

Conditions: Healthy
Being tested: ALXN1840
Keywords: Bioavailability, Healthy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ALXN1840Drug
Also called Tiomolibdate choline, Tiomolibdic acid
ALXN1840 will be administered orally.

Study groups in NCT04610580
Study group	Role	What they receive
Crossover ALXN1840 Sequence 1	Experimental	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. Receives: Drug: ALXN1840
Crossover ALXN1840 Sequence 2	Experimental	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. Receives: Drug: ALXN1840
Parallel Dose-proportionality Extension: ALXN1840 Dose 1	Experimental	Participants will receive a single dose of ALXN1840. Receives: Drug: ALXN1840
Parallel Dose-proportionality Extension: ALXN1840 Dose 2	Experimental	Participants will receive a single dose of ALXN1840. Receives: Drug: ALXN1840
Parallel Dose-proportionality Extension: ALXN1840 Dose 3	Experimental	Participants will receive a single dose of ALXN1840. Receives: Drug: ALXN1840
Parallel Dose-proportionality Extension: ALXN1840 Dose 4	Experimental	Participants will receive a single dose of ALXN1840. Receives: Drug: ALXN1840

What is being measured

The primary outcome is the main question the study is designed to answer.

Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via inductively coupled plasma-mass spectroscopy (ICP-MS).
Measured: predose (0.5 hour) and up to 336 hours postdose
Two-way Crossover Period: Cmax for PUF Mo
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose
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
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose
Two-way Crossover Period: AUCt for Plasma PUF Mo
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose

Secondary outcomes (5)

Dose-Proportionality Extension Period: Cmax For Plasma Total Mo
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCt For Plasma Total Mo
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Measured: predose (0.5 hour) and up to 336 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Jan 202126 Apr 2021

First posted30 Oct 2020
Study start31 Jan 2021
Primary completion24 Mar 2021
Study completion26 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This is a 2-period, 2-sequence, crossover study with a parallel group extension.
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04610580
Sponsor's protocol ID: ALXN1840-HV-109
Status last verified: Apr 2023
First submitted: 13 Oct 2020
Last updated: 16 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04610580
Acronym / sponsor ID: ALXN1840-HV-109
Conditions: Healthy
Keywords: Bioavailability, Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 31 Jan 2021 (actual)
Primary completion: 24 Mar 2021 (actual)
Study completion: 26 Apr 2021 (actual)
First posted: 30 Oct 2020 (actual)
Results: Posted 16 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Safety will be assessed throughout the study.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: This is a 2-period, 2-sequence, crossover study with a parallel group extension.

Arm	Type	Receives
Crossover ALXN1840 Sequence 1	Experimental	Drug: ALXN1840Participants 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.
Crossover ALXN1840 Sequence 2	Experimental	Drug: ALXN1840Participants 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.
Parallel Dose-proportionality Extension: ALXN1840 Dose 1	Experimental	Drug: ALXN1840Participants will receive a single dose of ALXN1840.
Parallel Dose-proportionality Extension: ALXN1840 Dose 2	Experimental	Drug: ALXN1840Participants will receive a single dose of ALXN1840.
Parallel Dose-proportionality Extension: ALXN1840 Dose 3	Experimental	Drug: ALXN1840Participants will receive a single dose of ALXN1840.
Parallel Dose-proportionality Extension: ALXN1840 Dose 4	Experimental	Drug: ALXN1840Participants will receive a single dose of ALXN1840.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ALXN1840Also: Tiomolibdate choline, Tiomolibdic acidALXN1840 will be administered orally.	Drug	Crossover ALXN1840 Sequence 1, Crossover ALXN1840 Sequence 2, Parallel Dose-proportionality Extension: ALXN1840 Dose 1, Parallel Dose-proportionality Extension: ALXN1840 Dose 2, Parallel Dose-proportionality Extension: ALXN1840 Dose 3, Parallel Dose-proportionality Extension: ALXN1840 Dose 4

Primary outcome

Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)
Time frame: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via inductively coupled plasma-mass spectroscopy (ICP-MS).
Two-way Crossover Period: Cmax for PUF Mo
Time frame: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
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
Time frame: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.
Two-way Crossover Period: AUCt for Plasma PUF Mo
Time frame: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.
Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo
Time frame: predose (0.5 hour) and up to 336 hours postdose
Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.

5 secondary outcomes

Dose-Proportionality Extension Period: Cmax For Plasma Total Mo
Time frame: predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo
Time frame: predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCt For Plasma Total Mo
Time frame: predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo
Time frame: predose (0.5 hour) and up to 336 hours postdose
Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo
Time frame: predose (0.5 hour) and up to 336 hours postdose

Results and safety

Results posted to the registry on 16 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Crossover: ALXN1840 Test Formulation (Treatment A) First, Then Reference Formulation (Treatment B)	24	22
Crossover: ALXN1840 Reference Formulation (Treatment B) First, Then Test Formulation (Treatment A)	24	22
Dose-proportionality Extension: ALXN1840 2.5 mg (Treatment C)	0	0
Dose-proportionality Extension: ALXN1840 5 mg (Treatment D)	0	0
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)	0	0
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)	0	0

Primary outcome: Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)

Time frame: predose (0.5 hour) and up to 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: nanograms (ng)/milliliter (mL)

Measure	Crossover: ALXN1840 Test Formulation (Treatment A) n = 45	Crossover: ALXN1840 Reference Formulation (Treatment B) n = 46
Value	227.0186 (47.5)	238.2725 (30.8)

Crossover: ALXN1840 Test Formulation (Treatment A) vs Crossover: ALXN1840 Reference Formulation (Treatment B): Geometric Least Square Mean Ratio (%): 95.0 (90% CI 82.1 to 110.0)

Population analysed: The Pharmacokinetic/Pharmacodynamic Set for the Two-way Crossover Periods (PKDS-CO) included all participants who received at least 1 dose of ALXN1840 in the Two-way Crossover Periods and had evaluable pharmacokinetic (PK) data for total and/or plasma ultrafiltrate (PUF) Mo (as surrogate measures of ALXN1840 PK) in plasma. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.

Primary outcome: Two-way Crossover Period: Cmax for PUF Mo

Time frame: predose (0.5 hour) and up to 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Crossover: ALXN1840 Test Formulation (Treatment A) n = 46	Crossover: ALXN1840 Reference Formulation (Treatment B) n = 46
Value	11.758 (43.7)	12.120 (40.7)

Crossover: ALXN1840 Test Formulation (Treatment A) vs Crossover: ALXN1840 Reference Formulation (Treatment B): Geometric Least Square Mean Ratio (%): 96.243 (90% CI 86.384 to 107.227)

Population analysed: The PKDS-CO included all participants who received at least 1 dose of ALXN1840 in the Two-way Crossover Periods and had evaluable PK data for total and/or PUF molybdenum (as surrogate measures of ALXN1840 PK) in plasma.

Primary outcome: 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

Time frame: predose (0.5 hour) and up to 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hours*ng/mL

Measure	Crossover: ALXN1840 Test Formulation (Treatment A) n = 45	Crossover: ALXN1840 Reference Formulation (Treatment B) n = 46
Value	8654.3114 (46.6)	9253.7266 (44.6)

Crossover: ALXN1840 Test Formulation (Treatment A) vs Crossover: ALXN1840 Reference Formulation (Treatment B): Geometric Least Square Mean Ratio (%): 94.9 (90% CI 81.6 to 110.5)

Primary outcome: Two-way Crossover Period: AUCt for Plasma PUF Mo

Time frame: predose (0.5 hour) and up to 336 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: hours*ng/mL

Measure	Crossover: ALXN1840 Test Formulation (Treatment A) n = 46	Crossover: ALXN1840 Reference Formulation (Treatment B) n = 46
Value	766.7655 (25.6)	811.7275 (27.2)

Crossover: ALXN1840 Test Formulation (Treatment A) vs Crossover: ALXN1840 Reference Formulation (Treatment B): Geometric Least Square Mean Ratio (%): 101.2 (90% CI 70.6 to 145.1)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 15. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Crossover: ALXN1840 Test Formulation (Treatment A)	0 of 46 (0%)	18 of 46 (39.1%)	0 of 46
Crossover: ALXN1840 Reference Formulation (Treatment B)	0 of 46 (0%)	20 of 46 (43.5%)	0 of 46
Dose-proportionality Extension: ALXN1840 2.5 mg (Treatment C)	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Dose-proportionality Extension: ALXN1840 5 mg (Treatment D	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
Dose-proportionality Extension: ALXN1840 10 mg (Treatment E)	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Dose-proportionality Extension: ALXN1840 30 mg (Treatment F)	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Eugene S. Swenson, MD, PhD study director

Alexion Pharmaceuticals, Inc.

Masood Sadaat, MD, MSc study chair

Alexion Pharmaceuticals, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ALXN1840 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo) (time frame: predose (0.5 hour) and up to 336 hours postdose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04610580.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.