Solid Tumors Harboring NTRK FusionPhase 1NCT04771390
Study to Compare How the Body Absorbs, Distributes and Excretes the Drug Selitrectinib (BAY2731954) Given as Two Different Tablet Formulations or as Liquid Formulations Including the Effect of Food on the Absorption, Distribution or Excretion of the Different Formulations in Healthy Participants
A Phase 1 study testing Selitrectinib (BAY2731954) Adult tablet, Selitrectinib (BAY2731954) Pediatric tablet and Selitrectinib (BAY2731954) Oral solution in people with Solid Tumors Harboring NTRK Fusion, run by Bayer at 2 sites in United States.
Trial summary
In this study, the researchers will compare 2 new tablet forms of BAY2731954 with liquid oral forms of BAY2731954. A maximum of 61 healthy volunteers aged 18 to 55 will be asked to participate. The study will have 2 parts. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Solid Tumors Harboring NTRK Fusion
- What is being tested?
- Selitrectinib (BAY2731954) Adult tablet, Selitrectinib (BAY2731954) Pediatric tablet and Selitrectinib (BAY2731954) Oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Feb 2021to 6 Jul 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
- Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac and neurologic examination
- Body mass index (BMI): ≥18.5 and ≤ 29.9 kg/m2, with body weight ≥50 kg
- Use of adequate contraception until 3 months after last study intervention
Who cannot join
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (e.g. seizures) or other organs (e.g. diabetes mellitus).
- Medical history of risk factors for Torsades de pointes (e.g. family history of Long QT Syndrome) or other arrhythmias
- Known severe allergies, allergies requiring therapy with corticosteroids, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated asymptomatic seasonal allergies such as non-severe hay fever during the time of study conduct).
- Regular use of medicines
- Regular alcohol consumption
- Smoking more than 5 cigarettes daily
- History of COVID-19 or current SARS-CoV-2 infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PAREXEL International, Baltimore
Baltimore, Maryland, 21225
Parexel International - Los Angeles
Glendale, California, 91206
About this study
Official title: An Open-label, Phase I Study to Evaluate the Relative Bioavailability, Food Effect and Pharmacokinetic Linearity of 2 New Tablet Formulations (Adult and Pediatric) of Selitrectinib (BAY 2731954) in Relative to Oral Suspension and the Liquid Service Formulation in Healthy Adult Participants
In this study, the researchers will compare 2 new tablet forms of BAY2731954 with liquid oral forms of BAY2731954. A maximum of 61 healthy volunteers aged 18 to 55 will be asked to participate.
The study will have 2 parts. In part 1 researchers want to gather information how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations. Participants will take the study drugs on 3 days separated by breaks of at least 3 days between each intake. The duration of this study part will be in total of up to 6 weeks from first screening visit to follow-up visit.
Read more
In part 2 of the study researchers want to study how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations with or without food or as 2 liquid oral formulations. Participants will take the study drugs on 4 days separated by breaks of at least 3 days between each intake. The duration of the second part of study part will be in total of up to 7 weeks from first screening visit to follow-up visit.
During the study, researchers will collect blood and urine samples. In addition, doctors will check the participants' overall health. They will also ask the participants if they have any medical problems.
- Conditions
- Solid Tumors Harboring NTRK Fusion
- Being tested
- Selitrectinib (BAY2731954) Adult tablet, Selitrectinib (BAY2731954) Pediatric tablet, Selitrectinib (BAY2731954) Oral solution, Selitrectinib (BAY2731954) Oral suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selitrectinib (BAY2731954) Adult tabletDrug
Tablet, oral administration
Selitrectinib (BAY2731954) Pediatric tabletDrug
Tablet, oral administration
Selitrectinib (BAY2731954) Oral solutionDrug
Oral solution after reconstitution
Selitrectinib (BAY2731954) Oral suspensionDrug
Oral suspension after reconstitution
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group A | Experimental | Participants will receive 3 single doses of selitrectinib in adult tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Adult tablet |
| Part 1: Group B | Experimental | Participants will receive 3 single doses of selitrectinib in pediatric tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Pediatric tablet |
| Part 2 (Group A): Dose A-B-C-D | Experimental | Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Adult tablet; Drug: Selitrectinib (BAY2731954) Oral solution; Drug: Selitrectinib (BAY2731954) Oral suspension |
| Part 2 (Group A): Dose B-C-A-D | Experimental | Participants will receive dose B, C, A and D sequentially. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Adult tablet; Drug: Selitrectinib (BAY2731954) Oral solution; Drug: Selitrectinib (BAY2731954) Oral suspension |
| Part 2 (Group A): Dose C-A-B-D | Experimental | Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Adult tablet; Drug: Selitrectinib (BAY2731954) Oral solution; Drug: Selitrectinib (BAY2731954) Oral suspension |
| Part 2 (Group B): Dose A-B-C-D | Experimental | Participants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Pediatric tablet; Drug: Selitrectinib (BAY2731954) Oral suspension |
| Part 2 (Group B): Dose B-D-A-C | Experimental | Participants will receive dose B, D, A and C sequentially. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Pediatric tablet; Drug: Selitrectinib (BAY2731954) Oral suspension |
| Part 2 (Group B): Dose C-A-D-B | Experimental | Participants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Pediatric tablet; Drug: Selitrectinib (BAY2731954) Oral suspension |
| Part 2 (Group B): Dose D-C-B-A | Experimental | Participants will receive dose D, C, B and A sequentially. The washing-out period between each dose is at least 3 days Receives: Drug: Selitrectinib (BAY2731954) Pediatric tablet; Drug: Selitrectinib (BAY2731954) Oral suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
Area under the plasma concentration vs. time curve from 0 to infinity after single dose
To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
Measured: Up to 48 hours after dosing
AUC(0-24)
Area under the plasma concentration vs. time curve from 0 to 24 hours after single dose
To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
Measured: Up to 24 hours after dosing
Cmax
Maximum observed drug concentration in measured matrix after single dose administration
To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
Measured: Up to 48 hours after dosing
Secondary outcomes (13)
AUC
Area under the plasma concentration vs. time curve from 0 to infinity after single dose.
To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solution
Measured: Up to 48 hours after dosing
AUC(0-24)
Area under the plasma concentration vs. time curve from 0 to 24 hours after single dose
To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solution
Measured: Up to 24 hours after dosing
Cmax
Maximum observed drug concentration in measured matrix after single dose administration
To evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral solution
Measured: Up to 48 hours after dosing
Number of participants with treatment emergent adverse events and severity of treatment emergent adverse events
Adverse events that occur or worsen after the first dose of study medication
Measured: Up to 7 weeks
Incidence of laboratory abnormalities, based on clinical safety laboratory assessments
Hematology, clinical chemistry and urinalysis test results
Measured: Up to 7 weeks
Ventricular rate
Measured: Up to 7 weeks
ECG PR interval
Measured: Up to 7 weeks
ECG QT interval
Measured: Up to 7 weeks
ECG QRS duration
Measured: Up to 7 weeks
Blood pressure in mmHg
Measured: Up to 7 weeks
Heart rate in bpm
bpm: beats per minute
Measured: Up to 7 weeks
Body temperature in Celsius
Measured: Up to 7 weeks
Respiratory rate in breaths/min
Measured: Up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start16 Feb 2021
- Primary completion20 May 2021
- Study completion6 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors Harboring NTRK FusionStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Part 1: sequential and non-randomized design Part 2: cross-over and randomized design
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771390
- Sponsor's protocol ID
- 21416
- Status last verified
- Aug 2021
- First submitted
- 5 Feb 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Study to Evaluate the Relative Bioavailability, Food Effect and Pharmacokinetic Linearity of 2 New Tablet Formulations (Adult and Pediatric) of Selitrectinib (BAY 2731954) in Relative to Oral Suspension and the Liquid Service Formulation in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04771390
- Acronym / sponsor ID
- 21416
- Conditions
- Solid Tumors Harboring NTRK Fusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 6 Jul 2021 (actual)
- First posted
- 25 Feb 2021 (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.
In this study, the researchers will compare 2 new tablet forms of BAY2731954 with liquid oral forms of BAY2731954. A maximum of 61 healthy volunteers aged 18 to 55 will be asked to participate.
The study will have 2 parts. In part 1 researchers want to gather information how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations. Participants will take the study drugs on 3 days separated by breaks of at least 3 days between each intake. The duration of this study part will be in total of up to 6 weeks from first screening visit to follow-up visit.
In part 2 of the study researchers want to study how the body absorbs, distributes and excretes the drug BAY2731954 given as two different tablet formulations with or without food or as 2 liquid oral formulations. Participants will take the study drugs on 4 days separated by breaks of at least 3 days between each intake. The duration of the second part of study part will be in total of up to 7 weeks from first screening visit to follow-up visit.
During the study, researchers will collect blood and urine samples. In addition, doctors will check the participants' overall health. They will also ask the participants if they have any medical problems.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Part 1: sequential and non-randomized design Part 2: cross-over and randomized design
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group A | Experimental | Drug: Selitrectinib (BAY2731954) Adult tabletParticipants will receive 3 single doses of selitrectinib in adult tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days |
| Part 1: Group B | Experimental | Drug: Selitrectinib (BAY2731954) Pediatric tabletParticipants will receive 3 single doses of selitrectinib in pediatric tablet formulation sequentially in 3 treatment periods. The washing-out period between each dose is at least 3 days |
| Part 2 (Group A): Dose A-B-C-D | Experimental | Drug: Selitrectinib (BAY2731954) Adult tablet, Drug: Selitrectinib (BAY2731954) Oral solution, Drug: Selitrectinib (BAY2731954) Oral suspensionParticipants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group A): Dose B-C-A-D | Experimental | Drug: Selitrectinib (BAY2731954) Adult tablet, Drug: Selitrectinib (BAY2731954) Oral solution, Drug: Selitrectinib (BAY2731954) Oral suspensionParticipants will receive dose B, C, A and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group A): Dose C-A-B-D | Experimental | Drug: Selitrectinib (BAY2731954) Adult tablet, Drug: Selitrectinib (BAY2731954) Oral solution, Drug: Selitrectinib (BAY2731954) Oral suspensionParticipants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group B): Dose A-B-C-D | Experimental | Drug: Selitrectinib (BAY2731954) Pediatric tablet, Drug: Selitrectinib (BAY2731954) Oral suspensionParticipants will receive dose A, B, C and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group B): Dose B-D-A-C | Experimental | Drug: Selitrectinib (BAY2731954) Pediatric tablet, Drug: Selitrectinib (BAY2731954) Oral suspensionParticipants will receive dose B, D, A and C sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group B): Dose C-A-D-B | Experimental | Drug: Selitrectinib (BAY2731954) Pediatric tablet, Drug: Selitrectinib (BAY2731954) Oral suspensionParticipants will receive dose C, A, B and D sequentially. The washing-out period between each dose is at least 3 days |
| Part 2 (Group B): Dose D-C-B-A | Experimental | Drug: Selitrectinib (BAY2731954) Pediatric tablet, Drug: Selitrectinib (BAY2731954) Oral suspensionParticipants will receive dose D, C, B and A sequentially. The washing-out period between each dose is at least 3 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants who are overtly healthy as determined by the investigator or medically qualified designee based on medical evaluation including medical history, laboratory tests, physical, cardiac and neurologic examination
- Body mass index (BMI): ≥18.5 and ≤ 29.9 kg/m2, with body weight ≥50 kg
- Use of adequate contraception until 3 months after last study intervention
Key exclusion criteria (7 listed)
- Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases), central nervous system (e.g. seizures) or other organs (e.g. diabetes mellitus).
- Medical history of risk factors for Torsades de pointes (e.g. family history of Long QT Syndrome) or other arrhythmias
- Known severe allergies, allergies requiring therapy with corticosteroids, non-allergic drug reactions, or (multiple) drug allergies (excluding untreated asymptomatic seasonal allergies such as non-severe hay fever during the time of study conduct).
- Regular use of medicines
- Regular alcohol consumption
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 |
|---|---|---|
| Selitrectinib (BAY2731954) Adult tabletTablet, oral administration | Drug | Part 1: Group A, Part 2 (Group A): Dose A-B-C-D, Part 2 (Group A): Dose B-C-A-D, Part 2 (Group A): Dose C-A-B-D |
| Selitrectinib (BAY2731954) Pediatric tabletTablet, oral administration | Drug | Part 1: Group B, Part 2 (Group B): Dose A-B-C-D, Part 2 (Group B): Dose B-D-A-C, Part 2 (Group B): Dose C-A-D-B, Part 2 (Group B): Dose D-C-B-A |
| Selitrectinib (BAY2731954) Oral solutionOral solution after reconstitution | Drug | Part 2 (Group A): Dose A-B-C-D, Part 2 (Group A): Dose B-C-A-D, Part 2 (Group A): Dose C-A-B-D |
| Selitrectinib (BAY2731954) Oral suspensionOral suspension after reconstitution | Drug | Part 2 (Group A): Dose A-B-C-D, Part 2 (Group A): Dose B-C-A-D, Part 2 (Group A): Dose C-A-B-D, Part 2 (Group B): Dose A-B-C-D, Part 2 (Group B): Dose B-D-A-C, Part 2 (Group B): Dose C-A-D-B, Part 2 (Group B): Dose D-C-B-A |
Primary outcome
AUC
Time frame: Up to 48 hours after dosing
Area under the plasma concentration vs. time curve from 0 to infinity after single dose To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
AUC(0-24)
Time frame: Up to 24 hours after dosing
Area under the plasma concentration vs. time curve from 0 to 24 hours after single dose To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
Cmax
Time frame: Up to 48 hours after dosing
Maximum observed drug concentration in measured matrix after single dose administration To evaluate the pharmacokinetic linearity of selitrectinib after a single dose of adult tablet and pediatric tablet and to evaluate the relative bioavailability of adult tablet and pediatric tablet formulation vs oral suspension formulation and the food effect on the bioavailability of 2 new tablet formulations
13 secondary outcomes
AUC
Time frame: Up to 48 hours after dosing
AUC(0-24)
Time frame: Up to 24 hours after dosing
Cmax
Time frame: Up to 48 hours after dosing
Number of participants with treatment emergent adverse events and severity of treatment emergent adverse events
Time frame: Up to 7 weeks
Incidence of laboratory abnormalities, based on clinical safety laboratory assessments
Time frame: Up to 7 weeks
Ventricular rate
Time frame: Up to 7 weeks
ECG PR interval
Time frame: Up to 7 weeks
ECG QT interval
Time frame: Up to 7 weeks
ECG QRS duration
Time frame: Up to 7 weeks
Blood pressure in mmHg
Time frame: Up to 7 weeks
Heart rate in bpm
Time frame: Up to 7 weeks
Body temperature in Celsius
Time frame: Up to 7 weeks
Respiratory rate in breaths/min
Time frame: Up to 7 weeks
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 25 Aug 2021.
- Individual participant dataSharing planned: No. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Selitrectinib (BAY2731954) Adult tablet, Selitrectinib (BAY2731954) Pediatric tablet and Selitrectinib (BAY2731954) Oral solution in people with Solid Tumors Harboring NTRK Fusion, run by Bayer at 2 sites 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 3 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 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
AUC (time frame: Up to 48 hours after dosing). 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?
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 25 Aug 2021.