HealthyPhase 1NCT03794323

A Study in Healthy Men to Find Out How Well Different Doses of BI 764122 Are Tolerated and Whether Food Affects the Amount of BI 764122 in the Blood

A Phase 1 study testing BI 764122 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

Completed

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

Trial summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses. Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 764122
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 76 participants
Where: 1 siteBelgium
Study dates: 30 Jan 2019to 12 Aug 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 years (inclusive)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:
Use of adequate contraception, e.g. use of condom (male subjects) plus any of the following methods (female partners): intrauterine device, hormonal contraception (e.g. implants, injectables, combined oral or vaginal contraceptives) that started at least 2 months prior to first drug administration to the male subject, or barrier method (e.g. diaphragm with spermicide), or surgically sterilised (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy), or postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH above 40 U/L and estradiol below 30 ng/L)
Sexually abstinent
Vasectomised (vasectomy at least 1 year prior to enrolment) in combination with a barrier method (e.g. condom) Unprotected sexual intercourse with a pregnant female partner and sperm donation is not allowed throughout the study and until 30 days after trial completion.

Who cannot join

Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)

Show all 24Show fewer

Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
Use of drugs within 30 days of planned administration of trial medication that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
Intake of an investigational drug in another clinical trial within 60 days of planned administration of investigational drug in the current trial, or concurrent participation in another clinical trial in which investigational drug is administered
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes per day)
Inability to refrain from smoking on specified trial days
Alcohol abuse (consumption of more than 30 g per day)
Drug abuse as per investigator judgment or positive drug screening
Blood donation of more than 100 mL within 30 days of planned administration of trial medication or intended blood donation during the trial
Intention to perform excessive physical activities within one week prior to the administration of trial medication or during the trial
Inability to comply with the dietary regimen of the trial site
A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
A history of additional risk factors for Torsade de Pointes (such as heart failure, hypokalaemia, or family history of Long QT Syndrome)
Subject is assessed as unsuitable for inclusion by the investigator, for instance, because the subject is not considered able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
In addition, the following trial-specific exclusion criteria apply:
History of acute pancreatitis

Trial locations and contacts

1 site in 1 country.

Belgium1 site

SGS Life Science Services - Clinical Research
Edegem, 2650

Other trials in Belgium

About this study

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 764122 (Single-blind, Partially Randomised, Placebo-controlled, Parallel (Sequential) Group Design) and the Effect of Food on BI 764122 (Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) in Healthy Male Subjects

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses.

The objective of the food effect (FE) part is to investigate the relative bioavailability of BI 764122 under fed and fasted conditions.

Conditions: Healthy
Being tested: BI 764122, Placebo

What participants receive

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

BI 764122Drug
Tablet
PlaceboDrug
Tablet

Study groups in NCT03794323
Study group	Role	What they receive
SRD part: BI 764122 4 mg	Experimental	4 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part. Receives: Drug: BI 764122
SRD part: BI 764122 12 mg	Experimental	1 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part. Receives: Drug: BI 764122
SRD part: BI 764122 25 mg	Experimental	2 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part. Receives: Drug: BI 764122
SRD part: BI 764122 50 mg	Experimental	5 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part. Receives: Drug: BI 764122
SRD part: BI 764122 100 mg	Experimental	1 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part. Receives: Drug: BI 764122
SRD part: BI 764122 200 mg	Experimental	2 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part. Receives: Drug: BI 764122
SRD part: BI 764122 300 mg	Experimental	3 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part. Receives: Drug: BI 764122
SRD part: BI 764122 400 mg	Experimental	4 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part. Receives: Drug: BI 764122
FE part: BI 764122 50 mg fasted/ BI 764122 50 mg fed	Experimental	5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part. Receives: Drug: BI 764122
FE part: BI 764122 50 mg fed/ BI 764122 50 mg fasted	Experimental	5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after an overnight fast of at least 10 h. FE part. Receives: Drug: BI 764122
Placebo	Placebo comparator	placebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part. Receives: Drug: Placebo

What is being measured

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

Percentage of Subjects With Drug-related Adverse Events
Percentage of subjects with drug-related adverse events.
Measured: From drug administration until 11 days thereafter for both single rising doses and food effect parts.

Secondary outcomes (2)

Area Under the Concentration-time Curve of BI 764122 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Area under the concentration-time curve of BI 764122 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Measured: Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.
Maximum Measured Concentration of BI 764122 in Plasma (Cmax)
Maximum measured concentration of BI 764122 in plasma (Cmax).
Measured: Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.

Timeline

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

30 Jan 201912 Aug 2019

First posted7 Jan 2019
Study start30 Jan 2019
Primary completion12 Aug 2019
Study completion12 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe 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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03794323
Sponsor's protocol ID: 1430-0001
Other IDs: 2018-003604-39, 2018
Status last verified: Jun 2022
First submitted: 4 Jan 2019
Last updated: 1 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1\. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

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?

See locations

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All Healthy trials

Study at a glance

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

Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 764122 (Single-blind, Partially Randomised, Placebo-controlled, Parallel (Sequential) Group Design) and the Effect of Food on BI 764122 (Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Design) in Healthy Male Subjects
ClinicalTrials.gov ID: NCT03794323
Acronym / sponsor ID: 1430-0001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 30 Jan 2019 (actual)
Primary completion: 12 Aug 2019 (actual)
Study completion: 12 Aug 2019 (actual)
First posted: 7 Jan 2019 (actual)
Results: Posted 1 May 2023

Clinical summary

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

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 764122 in healthy male subjects following oral administration of single rising doses.

The objective of the food effect (FE) part is to investigate the relative bioavailability of BI 764122 under fed and fasted conditions.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 11

Arm	Type	Receives
SRD part: BI 764122 4 mg	Experimental	Drug: BI 7641224 uncoated tablets of 1 milligram (mg) BI 764122 (total: 4 mg) were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.
SRD part: BI 764122 12 mg	Experimental	Drug: BI 7641221 film-coated tablet of 10 mg and 2 uncoated tablets of 1 mg BI 764122 (total: 12 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 25 mg	Experimental	Drug: BI 7641222 film-coated tablets of 10 mg and 5 uncoated tablets of 1 mg BI 764122 (total: 25 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 50 mg	Experimental	Drug: BI 7641225 film-coated tablets of 10 mg BI 764122 (total 50 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 100 mg	Experimental	Drug: BI 7641221 film-coated tablet of 100 mg BI 764122 (total: 100 mg) was administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 200 mg	Experimental	Drug: BI 7641222 film-coated tablets of 100 mg BI 764122 (total: 200 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 300 mg	Experimental	Drug: BI 7641223 film-coated tablets of 100 mg BI 764122 (total: 300 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
SRD part: BI 764122 400 mg	Experimental	Drug: BI 7641224 film-coated tablets of 100 mg BI 764122 (total: 400 mg) were administered as single oral dose with 240 mL of water after an overnight fast of at least 10 h. SRD part.
FE part: BI 764122 50 mg fasted/ BI 764122 50 mg fed	Experimental	Drug: BI 7641225 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after an overnight fast of at least 10 h, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast. Food effect (FE) part.
FE part: BI 764122 50 mg fed/ BI 764122 50 mg fasted	Experimental	Drug: BI 7641225 film-coated tablets of 10 mg BI 764122 (total: 50 mg) were administered as single oral dose with 240 mL water after a standardized high-fat, high-calorie breakfast, followed by wash-out period of at least 7 days followed by 5 film-coated tablets of 10 mg BI 764122 (total: 50 mg) administered as single oral dose with 240 mL water after an overnight fast of at least 10 h. FE part.
Placebo	Placebo comparator	Drug: Placeboplacebo matching in size and weight to corresponding uncoated or film-coated BI 764122 tablets were administered as single oral dose with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h). Single rising dose (SRD) part.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 50 years (inclusive)
Body Mass Index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

Key exclusion criteria (24 listed)

Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate (PR) or Electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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
BI 764122Tablet	Drug	FE part: BI 764122 50 mg fasted/ BI 764122 50 mg fed, FE part: BI 764122 50 mg fed/ BI 764122 50 mg fasted, SRD part: BI 764122 100 mg, SRD part: BI 764122 12 mg, SRD part: BI 764122 200 mg, SRD part: BI 764122 25 mg, SRD part: BI 764122 300 mg, SRD part: BI 764122 4 mg, SRD part: BI 764122 400 mg, SRD part: BI 764122 50 mg
PlaceboTablet	Drug	Placebo

Primary outcome

Percentage of Subjects With Drug-related Adverse Events
Time frame: From drug administration until 11 days thereafter for both single rising doses and food effect parts.
Percentage of subjects with drug-related adverse events.

2 secondary outcomes

Area Under the Concentration-time Curve of BI 764122 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf)
Time frame: Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.
Maximum Measured Concentration of BI 764122 in Plasma (Cmax)
Time frame: Within 30 minutes (min) before and 10, 20, 30, 45min and 1 hour (h), 1h 30min, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 120 h post administration.

Results and safety

Results posted to the registry on 1 May 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
Placebo	16	16
4 mg BI 764122	6	6
12 mg BI 764122	6	6
25 mg BI 764122	6	6
50 mg BI 764122	6	6
100 mg BI 764122	6	6
200 mg BI 764122	6	6
300 mg BI 764122	6	6
400 mg BI 764122	6	6
BI 764122 50 mg Fasted/ BI 764122 50 mg Fed	6	6
BI 764122 50 mg Fed/ BI 764122 50 mg Fasted	6	6

Primary outcome: Percentage of Subjects With Drug-related Adverse Events

Time frame: From drug administration until 11 days thereafter for both single rising doses and food effect parts.. Number. Unit: Percentage of participants

Measure	Placebo n = 16	4 mg BI 764122 n = 6	12 mg BI 764122 n = 6	25 mg BI 764122 n = 6	50 mg BI 764122 n = 6	100 mg BI 764122 n = 6	200 mg BI 764122 n = 6	300 mg BI 764122 n = 6	400 mg BI 764122 n = 6	50 mg BI 764122 Fasted n = 12	50 mg BI 764122 Fed n = 12
Value	6.3	0.0	16.7	0.0	0.0	0.0	0.0	0.0	0.0	8.3	8.3

Population analysed: Treated set (TS): The treated set included all subjects who were randomized and treated with at least 1 dose of study drug.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until 11 days thereafter for both single rising doses and food effect parts.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 16 (0%)	6 of 16 (37.5%)	0 of 16
4 mg BI 764122	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
12 mg BI 764122	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
25 mg BI 764122	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
50 mg BI 764122	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
100 mg BI 764122	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
200 mg BI 764122	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
300 mg BI 764122	0 of 6 (0%)	0 of 6 (0%)	0 of 6
400 mg BI 764122	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
50 mg BI 764122 Fasted	0 of 12 (0%)	3 of 12 (25%)	0 of 12
50 mg BI 764122 Fed	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: http://trials.boehringer-ingelheim.com/

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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 BI 764122 in people with Healthy, run by Boehringer Ingelheim at 1 site in Belgium.

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 8 inclusion and 24 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 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 Belgium. 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?

Yes. Results are posted in the registry (first posted 1 May 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?

Percentage of Subjects With Drug-related Adverse Events (time frame: From drug administration until 11 days thereafter for both single rising doses and food effect parts.). 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 NCT03794323.

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 May 2023.