HealthyPhase 1NCT05303324
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
A Phase 1 study testing ALXN1840 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B). Read more about this study
- Who is it for?
- Ages 18 to 45 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 siteUnited Kingdom
- Study dates
- 4 Jul 2019to 9 Oct 2019
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
- Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
- Willing to adhere to contraception requirements.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities.
Who cannot join
- Current or recurrent/chronic disease
- Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
- Acute or chronic hepatitis C virus infection.
- History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
- Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
- Participation (that is, last protocol-required study visit) in a clinical study within 90 days before initiation of dosing on Day 1.
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- Serum ceruloplasmin value outside of the normal range at Screening
- Female participants who were breastfeeding.
- Prior exposure to ALXN1840.
- Major surgery or hospitalization within 90 days prior to dosing on Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-Label, 2-Way Crossover Study to Assess the Single-Dose Pharmacokinetics of ALXN1840 Enteric-Coated Tablets at 2 Dose Strengths in Healthy Adult Subjects
To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).
- Conditions
- Healthy
- Being tested
- ALXN1840
- Keywords
- ALXN1840, Enteric-coated tablet, Pharmacokinetics, Pharmacodynamics, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN1840Drug
Also called Bis-choline Tetrathiomolybdate, Tiomolibdic Acid, WTX101 (formerly)
Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 (AB) | Experimental | Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows:
Period 1: ALXN1840 as a single EC tablet (Treatment A, reference). Period 2: ALXN1840 as three EC tablets (Treatment B, test).
Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement.
There was a washout period of at least 14 days between each ALXN1840 dosing. Receives: Drug: ALXN1840 |
| Sequence 2 (BA) | Experimental | Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows:
Period 1: ALXN1840 as three EC tablets (Treatment B, test). Period 2: ALXN1840 as a single EC tablet (Treatment A, reference).
Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement.
There was a washout period of at least 14 days between each ALXN1840 dosing. Receives: Drug: ALXN1840 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum
The pharmacokinetic (PK) data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via inductively coupled plasma-mass spectroscopy (ICP-MS).
Measured: Up to 240 hours postdose
Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt) of Total Molybdenum
The PK data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via ICP-MS.
Measured: Up to 240 hours postdose
Secondary outcomes (1)
Number of Participants With a Treatment-Emergent Adverse Event (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAE was an AE that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. A related TEAE was defined as having a reasonable possibility the study intervention caused the AE as assessed by the investigator. Serious AEs (SAEs) were defined as any untoward medical occurrence that met at least 1 of the following serious criteria: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, other medically important serious event. A summary of all SAEs and Other AEs (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start4 Jul 2019
- Primary completion9 Oct 2019
- Study completion9 Oct 2019
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303324
- Sponsor's protocol ID
- ALXN1840-HV-104
- Other IDs
- 2019-000516-28, 2019
- Status last verified
- Sep 2022
- First submitted
- 21 Mar 2022
- Last updated
- 2 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-Label, 2-Way Crossover Study to Assess the Single-Dose Pharmacokinetics of ALXN1840 Enteric-Coated Tablets at 2 Dose Strengths in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05303324
- Acronym / sponsor ID
- ALXN1840-HV-104
- Conditions
- Healthy
- Keywords
- ALXN1840, Enteric-coated tablet, Pharmacokinetics, Pharmacodynamics, 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
- 4 Jul 2019 (actual)
- Primary completion
- 9 Oct 2019 (actual)
- Study completion
- 9 Oct 2019 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Posted 2 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 (AB) | Experimental | Drug: ALXN1840Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows: Period 1: ALXN1840 as a single EC tablet (Treatment A, reference). Period 2: ALXN1840 as three EC tablets (Treatment B, test). Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement. There was a washout period of at least 14 days between each ALXN1840 dosing. |
| Sequence 2 (BA) | Experimental | Drug: ALXN1840Participants received ALXN1840 once in each Period as a single oral dose under fasted conditions as follows: Period 1: ALXN1840 as three EC tablets (Treatment B, test). Period 2: ALXN1840 as a single EC tablet (Treatment A, reference). Participants were discharged following the 240-hour post-dose procedures (approximately 10 days after dosing in each period) unless it was medically necessary to extend the confinement. There was a washout period of at least 14 days between each ALXN1840 dosing. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter squared, inclusive, at Screening.
- Negative serum pregnancy test at Screening and Day -1 for all women of childbearing potential.
- Willing to adhere to contraception requirements.
- Satisfactory medical assessment with no clinically significant or relevant abnormalities.
Key exclusion criteria (10 listed)
- Current or recurrent/chronic disease
- Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody at Screening.
- Acute or chronic hepatitis C virus infection.
- History of hypersensitivity to ALXN1840 or its excipients or any significant allergic reaction.
- Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
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: Bis-choline Tetrathiomolybdate, Tiomolibdic Acid, WTX101 (formerly)Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period. | Drug | Sequence 1 (AB), Sequence 2 (BA) |
Primary outcome
Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum
Time frame: Up to 240 hours postdose
The pharmacokinetic (PK) data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via inductively coupled plasma-mass spectroscopy (ICP-MS).
Area Under The Plasma Concentration Versus Time Curve From Time 0 (Dosing) to the Last Quantifiable Concentration (AUCt) of Total Molybdenum
Time frame: Up to 240 hours postdose
The PK data of plasma total molybdenum were analyzed in the scope of this study as a surrogate measure for ALXN1840. Whole blood samples were collected for the measurement of plasma concentrations of total molybdenum via ICP-MS.
1 secondary outcome
Number of Participants With a Treatment-Emergent Adverse Event (TEAEs)
Time frame: Baseline up to Day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 United Kingdom.
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 4 inclusion and 10 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 2 Aug 2023. 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 United Kingdom. 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 2 Aug 2023). 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?
Maximum Observed (Plasma) Concentration (Cmax) of Total Molybdenum (time frame: Up to 240 hours postdose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2023.