HealthyPhase 1NCT05319899

A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults

A Phase 1 study testing ALXN1840 and Omeprazole in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.

Completed

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

Official record

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Trial summary

This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Molybdenum. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: ALXN1840 and Omeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 20 Jan 2014to 24 Mar 2014
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 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Non-smoker
Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms.
Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
Willing and able to adhere to contraception requirements.

Who cannot join

Participant was mentally or legally incapacitated
History or presence of clinically significant medical or psychiatric condition or disease.
History of any illness that might have interfered with drug absorption.
History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
History or presence of alcoholism or drug abuse.
Female participants who were pregnant or lactating.

Show all 10Show fewer

Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
Serum ceruloplasmin and copper values outside of the normal range at screening.
On a diet incompatible with the on-study diet within the 28 days prior to the first ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat breakfast.
Participation in a previous clinical trial with ALXN1840.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Trial Site
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Phase 1, Single-Center, Randomized, 3-Period Crossover Study to Evaluate the Relative Bioavailability of WTX101 in Healthy Subjects After Single Dose Administration of a Non-Coated Formulation With and Without a Proton Pump Inhibitor and With a Proton Pump Inhibitor With and Without Food

Conditions: Healthy
Being tested: ALXN1840, Omeprazole
Keywords: ALXN1840, WTX101, Omeprazole

What participants receive

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

ALXN1840Drug
Also called WTX101 (formerly), Bis-choline tetrathiomolybdate, Tiomolibdate choline
ALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.
OmeprazoleDrug
Also called Prilosec
Omeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.

Study groups in NCT05319899
Study group	Role	What they receive
Sequence 1: ABC	Experimental	Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. There was a washout period of at least 14 days between each ALXN1840 dosing. Receives: Drug: ALXN1840; Drug: Omeprazole
Sequence 2: ACB	Experimental	Participants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. Receives: Drug: ALXN1840; Drug: Omeprazole
Sequence 3: BAC	Experimental	Participants received each treatment on 1 occasion: Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. There was a washout period of at least 14 days between each ALXN1840 dosing. Receives: Drug: ALXN1840; Drug: Omeprazole
Sequence 4: BCA	Experimental	Participants received each treatment on 1 occasion: Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. Receives: Drug: ALXN1840; Drug: Omeprazole
Sequence 5: CAB	Experimental	Participants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. Receives: Drug: ALXN1840; Drug: Omeprazole
Sequence 6: CBA	Experimental	Participants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing. Receives: Drug: ALXN1840; Drug: Omeprazole

What is being measured

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

Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)
AUC0-t was calculated by the linear trapezoidal method.
Measured: Predose (0 hour) up to 192 hours postdose
Maximum Measured Plasma Concentration (Cmax) of Total Mo
Measured: Predose (0 hour) up to 192 hours postdose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Day 1 through 14 days following final dose (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.

20 Jan 201424 Mar 2014

First posted8 Apr 2022
Study start20 Jan 2014
Primary completion24 Mar 2014
Study completion24 Mar 2014

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
Model description: This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study.
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05319899
Sponsor's protocol ID: WTX101-101
Other IDs: CA12887
Status last verified: Sep 2022
First submitted: 1 Apr 2022
Last updated: 1 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-Center, Randomized, 3-Period Crossover Study to Evaluate the Relative Bioavailability of WTX101 in Healthy Subjects After Single Dose Administration of a Non-Coated Formulation With and Without a Proton Pump Inhibitor and With a Proton Pump Inhibitor With and Without Food
ClinicalTrials.gov ID: NCT05319899
Acronym / sponsor ID: WTX101-101
Conditions: Healthy
Keywords: ALXN1840, WTX101, Omeprazole
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 20 Jan 2014 (actual)
Primary completion: 24 Mar 2014 (actual)
Study completion: 24 Mar 2014 (actual)
First posted: 8 Apr 2022 (actual)
Results: Posted 1 Aug 2023

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study.

Arm	Type	Receives
Sequence 1: ABC	Experimental	Drug: ALXN1840, Drug: OmeprazoleParticipants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Sequence 2: ACB	Experimental	Drug: ALXN1840, Drug: OmeprazoleParticipants received each treatment on 1 occasion: Period 1 (Treatment A): ALXN1840 following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Sequence 3: BAC	Experimental	Drug: ALXN1840, Drug: OmeprazoleParticipants received each treatment on 1 occasion: Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Sequence 4: BCA	Experimental	Drug: ALXN1840, Drug: OmeprazoleParticipants received each treatment on 1 occasion: Period 1 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 2 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Sequence 5: CAB	Experimental	Drug: ALXN1840, Drug: OmeprazoleParticipants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment A): ALXN1840 following an overnight fast. Period 3 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.
Sequence 6: CBA	Experimental	Drug: ALXN1840, Drug: OmeprazoleParticipants received each treatment on 1 occasion: Period 1 (Treatment C): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, approximately 30 minutes after the start of a high-fat breakfast. Period 2 (Treatment B): Omeprazole once daily in the morning of Days -5 to -1 following an overnight fast, omeprazole at Hour -1 on Day 1 following an overnight fast, and ALXN1840 at Hour 0 on Day 1, following an overnight fast. Period 3 (Treatment A): ALXN1840 following an overnight fast. There was a washout period of at least 14 days between each ALXN1840 dosing.

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Non-smoker
Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms.
Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
Willing and able to adhere to contraception requirements.

Key exclusion criteria (10 listed)

Participant was mentally or legally incapacitated
History or presence of clinically significant medical or psychiatric condition or disease.
History of any illness that might have interfered with drug absorption.
History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
History or presence of alcoholism or drug abuse.

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: WTX101 (formerly), Bis-choline tetrathiomolybdate, Tiomolibdate cholineALXN1840 (60 milligrams) was administered orally as non-coated capsules at Hour 0 on Day 1.	Drug	Sequence 1: ABC, Sequence 2: ACB, Sequence 3: BAC, Sequence 4: BCA, Sequence 5: CAB, Sequence 6: CBA
OmeprazoleAlso: PrilosecOmeprazole (20 milligrams) was administered orally as a delayed-release capsule in the morning of Days -5 to -1 and at Hour -1 on Day 1.	Drug	Sequence 1: ABC, Sequence 2: ACB, Sequence 3: BAC, Sequence 4: BCA, Sequence 5: CAB, Sequence 6: CBA

Primary outcome

Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)
Time frame: Predose (0 hour) up to 192 hours postdose
AUC0-t was calculated by the linear trapezoidal method.
Maximum Measured Plasma Concentration (Cmax) of Total Mo
Time frame: Predose (0 hour) up to 192 hours postdose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 1 through 14 days following final dose (up to Day 43)
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with the study drug and which did not necessarily have a causal relationship with the study drug. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to study drug. A TEAE was defined as an AE that started or worsened at the time of or after study drug administration. An AE that occurred during the washout period between drugs was considered treatment emergent to the last drug given. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

Results and safety

Results posted to the registry on 1 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence 1: ABC	3	3
Treatment Sequence 2: ACB	3	3
Treatment Sequence 3: BAC	3	3
Treatment Sequence 4: BCA	3	3
Treatment Sequence 5: CAB	3	3
Treatment Sequence 6: CBA	3	3

Primary outcome: Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)

Time frame: Predose (0 hour) up to 192 hours postdose. Mean (Standard Deviation). Unit: hours*ng/mL

Measure	Treatment A: ALXN1840 (Fasted) n = 18	Treatment B: Omeprazole + ALXN1840 (Fasted) n = 18	Treatment C: Omeprazole + ALXN1840 (Fed) n = 18
Value	14531 (6886)	18537 (4303)	14536 (3663)

Treatment A: ALXN1840 (Fasted) vs Treatment B: Omeprazole + ALXN1840 (Fasted): Geometric Mean Ratio (%): 140.63 (90% CI 118.94 to 166.26)
Treatment B: Omeprazole + ALXN1840 (Fasted) vs Treatment C: Omeprazole + ALXN1840 (Fed): Geometric Mean Ratio (%): 77.65 (90% CI 65.67 to 91.80)

Population analysed: Pharmacokinetic (PK) analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.

Primary outcome: Maximum Measured Plasma Concentration (Cmax) of Total Mo

Time frame: Predose (0 hour) up to 192 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Treatment A: ALXN1840 (Fasted) n = 18	Treatment B: Omeprazole + ALXN1840 (Fasted) n = 18	Treatment C: Omeprazole + ALXN1840 (Fed) n = 18
Value	330 (124)	401 (78.3)	385 (71.3)

Treatment A: ALXN1840 (Fasted) vs Treatment B: Omeprazole + ALXN1840 (Fasted): Geometric Mean Ratio (%): 128.23 (90% CI 112.99 to 145.52)
Treatment B: Omeprazole + ALXN1840 (Fasted) vs Treatment C: Omeprazole + ALXN1840 (Fed): Geometric Mean Ratio (%): 95.94 (90% CI 84.54 to 108.88)

Population analysed: PK analysis population included all participants who completed at least 2 periods of the study and had sufficient data for the determination of PK parameters.

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Time frame: Day 1 through 14 days following final dose (up to Day 43). Count of participants. Unit: Participants

Measure	Treatment A: ALXN1840 (Fasted) n = 18	Treatment B: Omeprazole + ALXN1840 (Fasted) n = 18	Treatment C: Omeprazole + ALXN1840 (Fed) n = 18
Value	6	5	6

Population analysed: All enrolled participants who received at least 1 dose of study drug.

Adverse events

Time frame: Day 1 through 14 days following final dose (up to Day 43). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: ALXN1840 (Fasted)	0 of 18 (0%)	6 of 18 (33.3%)	Not reported
Treatment B: Omeprazole + ALXN1840 (Fasted)	0 of 18 (0%)	5 of 18 (27.8%)	Not reported
Treatment C: Omeprazole + ALXN1840 (Fed)	0 of 18 (0%)	6 of 18 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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.

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 and Omeprazole in people with Healthy, run by Alexion Pharmaceuticals, Inc. at 1 site in United States.

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 1 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 States. 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 1 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?

Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo) (time frame: Predose (0 hour) up to 192 hours postdose). The study lists 3 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 NCT05319899.

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 1 Aug 2023.