HealthyPhase 1NCT04594252
Copper Balance in Healthy Participants Administered ALXN1840
A Phase 1 study testing ALXN1840 in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
The study will assess the change from baseline in mean daily copper balance in healthy participants with repeat-dose administrations of ALXN1840 over 2 weeks. 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
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2020to 18 Nov 2020
- 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
- Have regular bowel movements (at least once per day).
- Adequate venous access in the left or right arm to allow collection of study-required blood samples.
- Willing and able to adhere to all dietary requirements of the study.
- Body weight between 50 to 70 kilograms (kg) (inclusive) for female participants, and 65 to 85 kg (inclusive) for male participants, and body mass index within the range 18 to 25 kg/meters squared (inclusive).
- Willing and able to follow protocol-specified contraception requirements.
- Capable of giving signed informed consent.
Who cannot join
- Significant medical history (current or past).
- History or presence of gastrointestinal conditions including chronic constipation and irritable bowel syndrome.
- Supine blood pressure ≤ 90/60 millimeters of mercury (mmHg) or > 140/90 mmHg.
- Lymphoma, leukemia, or any malignancy within 3 years.
- Breast cancer within the past 10 years.
- Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit of normal at Screening.
Show all 11Show fewer
- Serum copper or serum ceruloplasmin below lower limit of normal on laboratory reference range at Screening.
- History of anemia or hemoglobin < 130 gram (g)/Liter (L) for men and hemoglobin < 115 g/L for women at Screening.
- History of benign ethnic neutropenia or absolute neutrophil count < 1500/microliter (uL), lymphocyte count below 1000/uL.
- QTcF> 450 millisecond (ms) for men and QTcF> 480 ms for women.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (except for asymptomatic gallstones).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Assess Copper Balance in Healthy Participants Following Administration of ALXN1840
The study will assess the change from baseline in mean daily copper balance in healthy participants with repeat-dose administrations of ALXN1840 over 2 weeks.
Read the detailed description
This study will also characterize the steady state absorption, distribution, metabolism, and excretion (mass balance) of total molybdenum, which is a surrogate measure of ALXN1840 disposition.
Safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- ALXN1840
- Keywords
- Copper Balance, Molybdenum Balance, Healthy, ALXN1840
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALXN1840Drug
Also called formerly WTX101
Administered orally as tablets.
| Study group | Role | What they receive |
|---|---|---|
| ALXN1840 | Experimental | Participants will be administered repeat doses of ALXN1840 30 milligrams (mg) for 15 days. Receives: Drug: ALXN1840 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15)
Copper balance was defined as the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.
Measured: Baseline, Days 4 to 15
Secondary outcomes (11)
Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing
Copper balance was defined by the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period.
Measured: Day 4 through Day 15
Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15)
Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.
Measured: Baseline, Days 12 to 15
Change From Baseline in Total Molybdenum Excretion in Urine and Feces Averaged Over 2 Weeks of Dosing (Days 4 to 15)
Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1. Molybdenum excretion for the Day 4 through Day 15 period included data averaged from Day 4 through Day 15.
Measured: Baseline, Days 4 to 15
Mean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15)
Molybdenum mass balance was defined as the difference in molybdenum input and molybdenum output. A negative molybdenum balance indicated greater molybdenum output than molybdenum intake. Molybdenum input was defined as the sum of all molybdenum input as measured in all food and fluids over the specified period. Molybdenum output was defined as the sum of all molybdenum output as measured in urine and feces over the specified collection period.
Measured: Day 1 through Day 15
Copper Quantified in Food, Drink, Feces, and Urine Averaged Over 2 Weeks of Dosing
Copper balance for the Day 4 through Day 15 period included data averaged from Day 4 through Day 15.
Measured: Days 4 to 15
Copper Quantified in Food, Drink, Feces, and Urine From Day 1 Through Day 30
Copper balance for the Day 1 through Day 30 period included data averaged from Day 1 through Day 30.
Measured: Day 1 through Day 30
Plasma Total Copper Concentration and Labile Bound Copper (LBC) Concentration
Measured: Day 15 (predose and 24 hours postdose)
Molybdenum Quantified in ALXN1840 Doses Given and in Food, Drink, Feces, And Urine
Molybdenum balance for the Day 1 through Day 30 period included data averaged from Day 1 through Day 30.
Measured: Day 1 through Day 30
Maximum Observed Plasma Concentration (Cmax) of Total Molybdenum and Plasma Ultrafiltrate (PUF) Molybdenum
Measured: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Total Molybdenum and PUF Molybdenum
Measured: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Observed Concentration at the End of the Dosing Interval (Ctau) of Total Molybdenum and PUF Molybdenum
Measured: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Jul 2020
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eugene S. Swenson, MD, PhD, Study director, Alexion Pharmaceuticals, Inc.Peter Ksenuk, MD, Study director, Alexion Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594252
- Sponsor's protocol ID
- ALXN1840-HV-108
- Status last verified
- Mar 2024
- First submitted
- 28 Sep 2020
- Last updated
- 19 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Assess Copper Balance in Healthy Participants Following Administration of ALXN1840
- ClinicalTrials.gov ID
- NCT04594252
- Acronym / sponsor ID
- ALXN1840-HV-108
- Conditions
- Healthy
- Keywords
- Copper Balance, Molybdenum Balance, Healthy, ALXN1840
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Posted 19 Aug 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 change from baseline in mean daily copper balance in healthy participants with repeat-dose administrations of ALXN1840 over 2 weeks.
Detailed description
This study will also characterize the steady state absorption, distribution, metabolism, and excretion (mass balance) of total molybdenum, which is a surrogate measure of ALXN1840 disposition.
Safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALXN1840 | Experimental | Drug: ALXN1840Participants will be administered repeat doses of ALXN1840 30 milligrams (mg) for 15 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Have regular bowel movements (at least once per day).
- Adequate venous access in the left or right arm to allow collection of study-required blood samples.
- Willing and able to adhere to all dietary requirements of the study.
- Body weight between 50 to 70 kilograms (kg) (inclusive) for female participants, and 65 to 85 kg (inclusive) for male participants, and body mass index within the range 18 to 25 kg/meters squared (inclusive).
- Willing and able to follow protocol-specified contraception requirements.
Key exclusion criteria (11 listed)
- Significant medical history (current or past).
- History or presence of gastrointestinal conditions including chronic constipation and irritable bowel syndrome.
- Supine blood pressure ≤ 90/60 millimeters of mercury (mmHg) or > 140/90 mmHg.
- Lymphoma, leukemia, or any malignancy within 3 years.
- Breast cancer within the past 10 years.
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: formerly WTX101Administered orally as tablets. | Drug | ALXN1840 |
Primary outcome
Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15)
Time frame: Baseline, Days 4 to 15
Copper balance was defined as the difference in copper input and copper output. A negative copper balance indicated greater copper output than copper intake. Copper input was defined as the sum of all copper input as measured in all food and fluids over the specified period. Copper output was defined as the sum of all copper output as measured in urine and feces over the specified collection period. Baseline was defined as the average of the nonmissing values on or before first study drug administration from Day -4 to Day -1.
11 secondary outcomes
Mean Daily Copper Balance Over Two Weeks of Repeated ALXN1840 Dosing
Time frame: Day 4 through Day 15
Change From Baseline in Mean Daily Molybdenum Balance at Steady State (Over Days 12 to 15)
Time frame: Baseline, Days 12 to 15
Change From Baseline in Total Molybdenum Excretion in Urine and Feces Averaged Over 2 Weeks of Dosing (Days 4 to 15)
Time frame: Baseline, Days 4 to 15
Mean Daily Molybdenum Balance Throughout the ALXN1840 Treatment Period (Day 1 Through Day 15)
Time frame: Day 1 through Day 15
Copper Quantified in Food, Drink, Feces, and Urine Averaged Over 2 Weeks of Dosing
Time frame: Days 4 to 15
Copper Quantified in Food, Drink, Feces, and Urine From Day 1 Through Day 30
Time frame: Day 1 through Day 30
Plasma Total Copper Concentration and Labile Bound Copper (LBC) Concentration
Time frame: Day 15 (predose and 24 hours postdose)
Molybdenum Quantified in ALXN1840 Doses Given and in Food, Drink, Feces, And Urine
Time frame: Day 1 through Day 30
Maximum Observed Plasma Concentration (Cmax) of Total Molybdenum and Plasma Ultrafiltrate (PUF) Molybdenum
Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Area Under the Plasma Concentration Versus Time Curve Over the Dosing Interval (AUCtau) of Total Molybdenum and PUF Molybdenum
Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Observed Concentration at the End of the Dosing Interval (Ctau) of Total Molybdenum and PUF Molybdenum
Time frame: Predose (within 1 hour prior to dosing) through 24 hours postdose on Day 1 and Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Peter Ksenuk, MD study director
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 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 6 inclusion and 11 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 19 Aug 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 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 19 Aug 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?
Change From Baseline in Mean Daily Copper Balance Over 2 Weeks of Repeated Daily ALXN1840 Dosing (Over Days 4 to 15) (time frame: Baseline, Days 4 to 15). 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 19 Aug 2024.