Healthy VolunteersPhase 1NCT03340220

Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of XEN1101.

A Phase 1 study testing XPF-008, Microcrystalline Cellulose and XPF-010 in people with Healthy Volunteers, run by Xenon Pharmaceuticals Inc. at 1 site in United Kingdom.

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: XPF-008, Microcrystalline Cellulose and XPF-010
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: 1 siteUnited Kingdom
Study dates: 13 Nov 2017to 26 Nov 2021
Phase: Phase 1
Are there results?: None posted in the registry

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

Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.50 and 30.00 kg/m2
Must agree to use effective methods of contraception, if applicable
Able to swallow capsules
Able to provide written, personally signed and dated informed consent form (ICF)

Who cannot join

Any history of epileptic seizures
Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study
Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale
Mental incapacity or lingual barriers precluding adequate understanding, cooperation, and compliance with the study
No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end
No smoking 60 days prior to dosing to study end
No soft drugs 3 months prior to Screening and hard drugs 2 years prior to Screening

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Richmond Pharmacology Ltd.
London, SE1 1YR

Other trials in United Kingdom

About this study

Official title: Phase 1, First-in-human, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of Single and Multiple Ascending Oral Doses of XEN1101 and Preliminary Open-label Pharmacodynamic Assessment in Healthy Subjects Addendum: Phase 1, Randomised, Multi Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Relative Bioavailability and Food Effect of Single and Multiple Ascending Doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment With Itraconazole

The XEN1101 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the safety, tolerability and PK of both single ascending doses (SAD) and multiple ascending doses (MAD) of XEN1101 in healthy subjects. In addition to safety and PK data, the clinical trial has been designed to include a pharmacodynamic read-out by incorporating a pilot transcranial magnetic stimulation (TMS) sub-study. The TMS model sub-study is designed to demonstrate delivery of XEN1101 into the central nervous system and to observe a change in cortical excitability as measured by EEG and/or electromyographic (EMG) activity.

Part 3, 4 and 5: Phase 1, randomised, multi part study to evaluate the safety, tolerability, PK, relative bioavailability and food effect of single and multiple ascending doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment with Itraconazole.

Read the detailed description

Part 1 will study safety, tolerability, PK of single ascending doses (SAD) of XPF-008 as well as the impact and variability of single ascending doses of XPF-008 on TMS.

Part 2 will study the safety, tolerability and PK of multiple ascending doses (MAD) of XPF-008

Part 3 will explore dose proportionality of XPF-010 and confirm dosing for subsequent cohorts, and the food effect and relative bioavailability of XPF-010 compared to XPF-008.

Part 4 will explore multiple dose PK.

Part 5 will explore the drug-drug interaction of XPF-010, when given with itraconazole.

Conditions: Healthy Volunteers
Being tested: XPF-008, Microcrystalline Cellulose, XPF-010, Itraconazole 400mg

What participants receive

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

XPF-008Drug
Capsule filled with XEN1101
Microcrystalline CelluloseDrug
Placebo capsule
XPF-010Drug
Capsule filled with XEN1101
Itraconazole 400mgDrug
Oral

Study groups in NCT03340220
Study group	Role	What they receive
Drug: XEN1101 XPF-008 Formulation Oral	Experimental	XEN1101 XPF-008 Formulation Part 1 - Single ascending dose: Single oral dose for each cohort Part 2 - Multiple ascending dose: 7 days of single oral dose daily for each cohort Receives: Drug: XPF-008
Placebo - Microcrystalline cellulose oral	Placebo comparator	Part 1- Single Ascending Dose: Single oral dose for each cohort Part 2 - Multiple Ascending Dose: 7 days of single oral dose daily for each cohort Receives: Drug: Microcrystalline Cellulose
Drug: XEN1101 XPF-008 Formulation Oral Drug: XEN1101 XPF-010 Formulation Oral	Experimental	XEN1101 XPF-008 and XPF-010 Formulation Cross Over Part 3 will explore dose proportionality of XPF-010 and confirm dosing for subsequent cohorts, and the food effect and relative bioavailability of XPF-010 compared to XPF-008 Receives: Drug: XPF-010
Drug: XEN1101 XPF-010 Formulation Oral	Experimental	XEN1101 XPF-010 Formulation Oral Part 4 will explore multiple dose PK Receives: Drug: XPF-010
Drug: XEN1101 XPF-010 Formulation Oral Drug: Itraconazole 400mg Oral	Experimental	XEN1101 XPF-010 Formulation + Itraconazole Part 5 will explore the drug-drug interaction of XPF-010, when given with itraconazole (400mg, single dose, oral solution, fasted) Receives: Drug: Itraconazole 400mg

What is being measured

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

Parts 1 & 2: Number of Participants with Adverse Events (AEs)
To assess AEs as a criteria of safety and tolerability
Measured: From screening (28 days prior to Day 1) through to 30 days post-final dose
Parts 1 & 2: Resting electrocardiogram (ECG)
To assess ECG as a criteria of safety and tolerability
Measured: At screening (28 days prior to Day 1) through to 7 days post-final dose
Parts 1 & 2: Vital signs
To assess vital signs as a criteria of safety and tolerability
Measured: At screening (28 days prior to Day 1) through to 7 days post-final dose
Part 3a: Maximum Observed Plasma Concentration (Cmax) of XEN1101
To characterize the PK profile of XEN1101 and M11 (a metabolite of XEN1101) in plasma of single ascending, oral doses of XPF-010
Measured: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3a: Area under the plasma concentration-time curve (AUC) of XEN1101
To characterize the PK profile of XEN1101 and M11 (a metabolite of XEN1101) in plasma of single ascending, oral doses of XPF-010
Measured: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3a: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of XEN1101 (XPF-010)
Measured: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3b: Maximum Observed Plasma Concentration (Cmax) of XEN1101
To assess the Food Effect on PK (Cmax) and the relative bioavailability/comparability (Cmax) of XEN1101 following single oral doses of XPF-010 (fed), XPF-008 (fed) and XPF-010 (fasted)
Measured: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3b: Area under the plasma concentration-time curve (AUC) of XEN1101
To assess the Food Effect on PK (AUC0-240h) and the relative bioavailability/comparability (AUC0-240h) of XEN1101 following single oral doses of XPF-010 (fed), XPF-008 (fed) and XPF-010 (fasted)
Measured: At screening (27 days prior to Day -1) through to 31 days post dose
Part 3b: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of XEN1101
Measured: At screening (27 days prior to Day -1) through to 31 days post dose
Part 4: Maximum Observed Plasma Concentration (Cmax) of XEN1101
To characterize the PK profile of XEN1101 and M11 (metabolite of XEN1101) in plasma of multiple daily oral doses of XPF-010
Measured: At screening (27 days prior to Day -1) through to 51 days post dose
Part 4: Area under the plasma concentration-time curve (AUC) of XEN1101
To characterize the PK profile of XEN1101 and M11 (metabolite of XEN1101) in plasma of multiple daily oral doses of XPF-010
Measured: At screening (27 days prior to Day -1) through to 51 days post dose
Part 4: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of XEN1101 (XPF-010)
Measured: At screening (27 days prior to Day -1) through to 51 days post dose
Part 5: Maximum Observed Plasma Concentration (Cmax) of XEN1101
To assess the PK of XEN1101 (XPF-010) in the presence and absence of itraconazole
Measured: Day 10 and Day 11
Part 5: Area under the plasma concentration-time curve (AUC) of XEN1101
To assess the PK of XEN1101 (XPF-010) in the presence and absence of itraconazole
Measured: Day 10 and Day 11
Part 5: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
To evaluate the safety and tolerability of XEN1101 (XPF-010)
Measured: At screening (27 days prior to Day -1) through to 51 days post dose

Secondary outcomes (5)

Parts 1 & 2: Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed plasma concentration in ng/mL
Measured: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Time to the Maximum Observed Plasma Concentration (Tmax)
Tmax is the time in hours to reach Cmax following dosing
Measured: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Terminal elimination half-life (t1/2)
The time in hours required for the plasma level of the study drug to decrease by one-half during the terminal elimination phase
Measured: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)
The area under the plasma concentration-time curve [in ng.h/mL] from time zero to the time corresponding to the last quantifiable plasma concentration
Measured: Day 1 predose through to 7 days post-final dose
Parts 3 to 5: Cardiac Safety
To evaluate the cardiovascular safety profile of XEN1101 (XPF-010), assessing potential ECG interval changes from baseline following dosing, in particular any effects on the QTc interval.
Measured: At screening (27 days prior to Day -1) through to 11 days post dose for Parts 3a and 3b and at screening (27days prior to Day -1) through to Day 21

Timeline

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

13 Nov 201726 Nov 2021

First posted13 Nov 2017
Study start13 Nov 2017
Primary completion26 Nov 2021
Study completion26 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
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: Non-randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03340220
Sponsor's protocol ID: XPF-008-101a
Other IDs: 2017-003168-11, C17030, 2017
Status last verified: May 2023
First submitted: 31 Oct 2017
Last updated: 11 May 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
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 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, First-in-human, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and PK of Single and Multiple Ascending Oral Doses of XEN1101 and Preliminary Open-label Pharmacodynamic Assessment in Healthy Subjects Addendum: Phase 1, Randomised, Multi Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Relative Bioavailability and Food Effect of Single and Multiple Ascending Doses of XEN1101 and Preliminary Drug-Drug Interaction Assessment With Itraconazole
ClinicalTrials.gov ID: NCT03340220
Acronym / sponsor ID: XPF-008-101a
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Xenon Pharmaceuticals Inc.Industry (pharma, biotech, devices)
Study start: 13 Nov 2017 (actual)
Primary completion: 26 Nov 2021 (actual)
Study completion: 26 Nov 2021 (actual)
First posted: 13 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

Part 1 will study safety, tolerability, PK of single ascending doses (SAD) of XPF-008 as well as the impact and variability of single ascending doses of XPF-008 on TMS.

Part 2 will study the safety, tolerability and PK of multiple ascending doses (MAD) of XPF-008

Part 3 will explore dose proportionality of XPF-010 and confirm dosing for subsequent cohorts, and the food effect and relative bioavailability of XPF-010 compared to XPF-008.

Part 4 will explore multiple dose PK.

Part 5 will explore the drug-drug interaction of XPF-010, when given with itraconazole.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
Drug: XEN1101 XPF-008 Formulation Oral	Experimental	Drug: XPF-008XEN1101 XPF-008 Formulation Part 1 - Single ascending dose: Single oral dose for each cohort Part 2 - Multiple ascending dose: 7 days of single oral dose daily for each cohort
Placebo - Microcrystalline cellulose oral	Placebo comparator	Drug: Microcrystalline CellulosePart 1- Single Ascending Dose: Single oral dose for each cohort Part 2 - Multiple Ascending Dose: 7 days of single oral dose daily for each cohort
Drug: XEN1101 XPF-008 Formulation Oral Drug: XEN1101 XPF-010 Formulation Oral	Experimental	Drug: XPF-010XEN1101 XPF-008 and XPF-010 Formulation Cross Over Part 3 will explore dose proportionality of XPF-010 and confirm dosing for subsequent cohorts, and the food effect and relative bioavailability of XPF-010 compared to XPF-008
Drug: XEN1101 XPF-010 Formulation Oral	Experimental	Drug: XPF-010XEN1101 XPF-010 Formulation Oral Part 4 will explore multiple dose PK
Drug: XEN1101 XPF-010 Formulation Oral Drug: Itraconazole 400mg Oral	Experimental	Drug: Itraconazole 400mgXEN1101 XPF-010 Formulation + Itraconazole Part 5 will explore the drug-drug interaction of XPF-010, when given with itraconazole (400mg, single dose, oral solution, fasted)

Who may qualify

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

Key inclusion criteria (4 listed)

Healthy male or females aged between 18 and 55 years inclusive with a body mass index (BMI) between 18.50 and 30.00 kg/m2
Must agree to use effective methods of contraception, if applicable
Able to swallow capsules
Able to provide written, personally signed and dated informed consent form (ICF)

Key exclusion criteria (7 listed)

Any history of epileptic seizures
Any current and relevant history of significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk, affect clinical or laboratory results, or the subject's ability to participate in the study
Answering "yes" to any of the questions within the Columbia Suicide Severity Rating Scale
Mental incapacity or lingual barriers precluding adequate understanding, cooperation, and compliance with the study
No prescription or over-the-counter (OTC) medications (except hormonal contraception), herbal or dietary supplements OTC medications 14 days prior to dosing to study end

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
XPF-008Capsule filled with XEN1101	Drug	Drug: XEN1101 XPF-008 Formulation Oral
Microcrystalline CellulosePlacebo capsule	Drug	Placebo - Microcrystalline cellulose oral
XPF-010Capsule filled with XEN1101	Drug	Drug: XEN1101 XPF-008 Formulation Oral Drug: XEN1101 XPF-010 Formulation Oral, Drug: XEN1101 XPF-010 Formulation Oral
Itraconazole 400mgOral	Drug	Drug: XEN1101 XPF-010 Formulation Oral Drug: Itraconazole 400mg Oral

Primary outcome

Parts 1 & 2: Number of Participants with Adverse Events (AEs)
Time frame: From screening (28 days prior to Day 1) through to 30 days post-final dose
To assess AEs as a criteria of safety and tolerability
Parts 1 & 2: Resting electrocardiogram (ECG)
Time frame: At screening (28 days prior to Day 1) through to 7 days post-final dose
To assess ECG as a criteria of safety and tolerability
Parts 1 & 2: Vital signs
Time frame: At screening (28 days prior to Day 1) through to 7 days post-final dose
To assess vital signs as a criteria of safety and tolerability
Part 3a: Maximum Observed Plasma Concentration (Cmax) of XEN1101
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
To characterize the PK profile of XEN1101 and M11 (a metabolite of XEN1101) in plasma of single ascending, oral doses of XPF-010
Part 3a: Area under the plasma concentration-time curve (AUC) of XEN1101
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
To characterize the PK profile of XEN1101 and M11 (a metabolite of XEN1101) in plasma of single ascending, oral doses of XPF-010
Part 3a: Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
To evaluate the safety and tolerability of XEN1101 (XPF-010)
Part 3b: Maximum Observed Plasma Concentration (Cmax) of XEN1101
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
To assess the Food Effect on PK (Cmax) and the relative bioavailability/comparability (Cmax) of XEN1101 following single oral doses of XPF-010 (fed), XPF-008 (fed) and XPF-010 (fasted)
Part 3b: Area under the plasma concentration-time curve (AUC) of XEN1101
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
To assess the Food Effect on PK (AUC0-240h) and the relative bioavailability/comparability (AUC0-240h) of XEN1101 following single oral doses of XPF-010 (fed), XPF-008 (fed) and XPF-010 (fasted)
Part 3b: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
Time frame: At screening (27 days prior to Day -1) through to 31 days post dose
To evaluate the safety and tolerability of XEN1101
Part 4: Maximum Observed Plasma Concentration (Cmax) of XEN1101
Time frame: At screening (27 days prior to Day -1) through to 51 days post dose
To characterize the PK profile of XEN1101 and M11 (metabolite of XEN1101) in plasma of multiple daily oral doses of XPF-010
Part 4: Area under the plasma concentration-time curve (AUC) of XEN1101
Time frame: At screening (27 days prior to Day -1) through to 51 days post dose
To characterize the PK profile of XEN1101 and M11 (metabolite of XEN1101) in plasma of multiple daily oral doses of XPF-010
Part 4: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
Time frame: At screening (27 days prior to Day -1) through to 51 days post dose
To evaluate the safety and tolerability of XEN1101 (XPF-010)
Part 5: Maximum Observed Plasma Concentration (Cmax) of XEN1101
Time frame: Day 10 and Day 11
To assess the PK of XEN1101 (XPF-010) in the presence and absence of itraconazole
Part 5: Area under the plasma concentration-time curve (AUC) of XEN1101
Time frame: Day 10 and Day 11
To assess the PK of XEN1101 (XPF-010) in the presence and absence of itraconazole
Part 5: Frequency and severity of TEAEs, treatment-emergent SAEs, and TEAEs leading to treatment discontinuations
Time frame: At screening (27 days prior to Day -1) through to 51 days post dose
To evaluate the safety and tolerability of XEN1101 (XPF-010)

5 secondary outcomes

Parts 1 & 2: Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Time to the Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Terminal elimination half-life (t1/2)
Time frame: Day 1 predose through to 7 days post-final dose
Parts 1 & 2: Area Under the Plasma Concentration-Time Curve from Time Zero to the Time of the Last Quantifiable Plasma Concentration (AUC0-last)
Time frame: Day 1 predose through to 7 days post-final dose
Parts 3 to 5: Cardiac Safety
Time frame: At screening (27 days prior to Day -1) through to 11 days post dose for Parts 3a and 3b and at screening (27days prior to Day -1) through to Day 21

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.

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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.

Gregory N Beatch, PhD study director

Xenon 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 XPF-008, Microcrystalline Cellulose and XPF-010 in people with Healthy Volunteers, run by Xenon 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 7 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 11 May 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Parts 1 & 2: Number of Participants with Adverse Events (AEs) (time frame: From screening (28 days prior to Day 1) through to 30 days post-final dose). The study lists 15 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 NCT03340220.

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 11 May 2023.