HealthyPhase 1NCT04771286

A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body

A Phase 1 study testing BI 1015550 (C-14) in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.

Completed

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

Trial summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 1015550 and its metabolite BI 764333 (M480), [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose BI 1015550 (C-14) administered to healthy male subjects. Read more about this study

Who is it for?: Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: BI 1015550 (C-14)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteNetherlands
Study dates: 25 Mar 2021to 17 May 2021
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 65 years
Men only
Healthy volunteers accepted
Adult, Older 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 electrocardiograms (ECG), and clinical laboratory tests
Age of 18 to 65 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 screening until 90 days after trial completion:
Use of adequate contraception of the female partner, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device, which started at least two months prior to first study drug administration or barrier method (e.g. diaphragm with spermicide) or,

Show all 10Show fewer

Sexually abstinent or,
A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or,
Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion, or bilateral oophorectomy) or,
Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of Follicle-Stimulating Hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 (beats per minute) 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 9Show 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
Further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

ICON
Groningen, 9728 NZ

Other trials in Netherlands

About this study

Official title: A Phase I, Open-label, Non-randomized, Single-dose, Single-arm, Single-period Study to Investigate the Metabolism and Pharmacokinetics of [C-14]-Labelled BI 1015550 After Oral Administration in Healthy Male Subjects

The primary objective is:

To assess the mass balance recovery of [14C]-radioactivity from urine and faeces as well as vomit in case of occurrence after a single oral dose of BI 1015550 (C-14) administered to healthy male subjects

The secondary objectives are:

To assess the pharmacokinetics of [C-14]-BI 1015550 and BI 1015550 as well as its metabolite BI 764333 in plasma following a single oral dose of BI 1015550 (C-14)
To assess the safety and tolerability of BI 1015550

Conditions: Healthy
Being tested: BI 1015550 (C-14)

What participants receive

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

BI 1015550 (C-14)Drug
Also called Nerandomilast, JASCAYD®
BI 1015550 (C-14)

Study groups in NCT04771286
Study group	Role	What they receive
BI 1015550 (C-14)	Experimental	Participants received a single dose of 18 milligrams (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg [14C]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours. Receives: Drug: BI 1015550 (C-14)

What is being measured

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

Percentage of the Amount of [14C]-Radioactivity Excreted Among the Administered Single Oral Dose of [14-C] BI 1015550-EQ in Urine (Feurine, 0-tz), Faeces (Fefaeces, 0-tz) and Vomit (Fevomit, 0-tz)
0-tz refers to 0 until latest individually available cumulative fraction after drug administration.
Vomit=Not applicable. Amount excreted calculated by volume multiplied with concentration of sample for respective time interval. Amount then refers to administered dose as fraction excreted in percent (dose=100%), done cumulatively.
Time frames:
Urine: on Day -1 or 1 -2 hours (h) before drug administration + at 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 h after drug administration.
Faeces: on Day -1 or 1 -2 hours (h) before drug administration + 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 h after drug administration.
Thereafter, if warranted, 24 h collections for urine and faeces were to be performed every 7 days starting on Day 16, at Day 16-17, Day 23-24, Day 30-31. When the release criteria for radioactivity recovery had been met then urine/faeces sampling was stopped (earliest stop on Day 10).
Measured: From Day -1 or Day 1 - 2 hours (h) before drug administration until release criteria for radioactivity recovery had been met, up to Day 30-31. See also description section.

Secondary outcomes (7)

Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Measured: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Area Under the Concentration-time Curve of BI 764333 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of BI 764333 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
BI 764333 is a metabolite of BI 1015550.
Measured: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Area Under the Concentration-time Curve of [14-C] BI 1015550-EQ in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of [14-C] BI 1015550-EQ in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is presented.
Measured: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
Maximum measured concentration of BI 1015550 in plasma (Cmax) is presented.
Measured: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum Measured Concentration of BI 764333 in Plasma (Cmax)
Maximum measured concentration of BI 764333 in plasma (Cmax) is presented. BI 764333 is a metabolite of BI 1015550.
Measured: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum Measured Concentration of [14-C] BI 1015550-EQ in Plasma (Cmax)
Maximum measured concentration of [14-C] BI 1015550-EQ in plasma (Cmax) is presented.
Measured: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Percentage of Participants With Treatment-emergent Adverse Events (TEAE)
Percentage of participants with treatment-emergent adverse events (TEAE) is presented.
Percentages were rounded to one decimal place.
Measured: From the first administration of the trial drug until end of the trial, up to 31 days.

Timeline

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

25 Mar 202117 May 2021

First posted25 Feb 2021
Study start25 Mar 2021
Primary completion17 May 2021
Study completion17 May 2021

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.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04771286
Sponsor's protocol ID: 1305-0016
Other IDs: 2020-005934-13
Status last verified: Oct 2025
First submitted: 23 Feb 2021
Last updated: 28 Nov 2025
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: https://www.mystudywindow.com/msw/datasharing

Publications

Jappar D, Wu J, Burkard U, Sharma A, Coeck C, Zoz D, Yu Y. Pharmacokinetics and Safety of Nerandomilast in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2026 Aug 6. doi: 10.1007/s13318-026-01027-9. Online ahead of print.
PubMed 42563128

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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Study at a glance

From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-label, Non-randomized, Single-dose, Single-arm, Single-period Study to Investigate the Metabolism and Pharmacokinetics of [C-14]-Labelled BI 1015550 After Oral Administration in Healthy Male Subjects
ClinicalTrials.gov ID: NCT04771286
Acronym / sponsor ID: 1305-0016
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 25 Mar 2021 (actual)
Primary completion: 17 May 2021 (actual)
Study completion: 17 May 2021 (actual)
First posted: 25 Feb 2021 (actual)
Results: Posted 28 Nov 2025

Clinical summary

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

The primary objective is:

To assess the mass balance recovery of [14C]-radioactivity from urine and faeces as well as vomit in case of occurrence after a single oral dose of BI 1015550 (C-14) administered to healthy male subjects

The secondary objectives are:

To assess the pharmacokinetics of [C-14]-BI 1015550 and BI 1015550 as well as its metabolite BI 764333 in plasma following a single oral dose of BI 1015550 (C-14)
To assess the safety and tolerability of BI 1015550

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 1015550 (C-14)	Experimental	Drug: BI 1015550 (C-14)Participants received a single dose of 18 milligrams (mg) BI 1015550 (C-14) consisting of 17.16 mg non-labelled BI 1015550 mixed with 0.84 mg [14C]BI 1015550-EQ as 36 milliliters (mL) of oral solution (0.5 mg/mL) labelled with a radioactive dose of 3.7 megaBecquerel (MBq) (100 micro Curie (μ Ci), corresponding to 0.2864 miliSievert (mSV)) on Day 1 with 240 mL of water after an overnight fast of at least 10 hours.

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 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 electrocardiograms (ECG), and clinical laboratory tests
Age of 18 to 65 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 screening until 90 days after trial completion:

Key exclusion criteria (9 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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 (beats per minute) 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 1015550 (C-14)Also: Nerandomilast, JASCAYD®BI 1015550 (C-14)	Drug	BI 1015550 (C-14)

Primary outcome

Percentage of the Amount of [14C]-Radioactivity Excreted Among the Administered Single Oral Dose of [14-C] BI 1015550-EQ in Urine (Feurine, 0-tz), Faeces (Fefaeces, 0-tz) and Vomit (Fevomit, 0-tz)
Time frame: From Day -1 or Day 1 - 2 hours (h) before drug administration until release criteria for radioactivity recovery had been met, up to Day 30-31. See also description section.
0-tz refers to 0 until latest individually available cumulative fraction after drug administration. Vomit=Not applicable. Amount excreted calculated by volume multiplied with concentration of sample for respective time interval. Amount then refers to administered dose as fraction excreted in percent (dose=100%), done cumulatively. Time frames: Urine: on Day -1 or 1 -2 hours (h) before drug administration + at 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 h after drug administration. Faeces: on Day -1 or 1 -2 hours (h) before drug administration + 0-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216 h after drug administration. Thereafter, if warranted, 24 h collections for urine and faeces were to be performed every 7 days starting on Day 16, at Day 16-17, Day 23-24, Day 30-31. When the release criteria for radioactivity recovery had been met then urine/faeces sampling was stopped (earliest stop on Day 10).

7 secondary outcomes

Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Area Under the Concentration-time Curve of BI 764333 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Area Under the Concentration-time Curve of [14-C] BI 1015550-EQ in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
Time frame: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum Measured Concentration of BI 764333 in Plasma (Cmax)
Time frame: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Maximum Measured Concentration of [14-C] BI 1015550-EQ in Plasma (Cmax)
Time frame: Within 2 hours (h) before drug administration and 30 minutes (min), 45 min, 1h, 1h 30 min, 2h, 4h, 8h, 12h, 24h, 36h, 48h, 96h, 144h, 168h, 192h and 216h after drug administration.
Percentage of Participants With Treatment-emergent Adverse Events (TEAE)
Time frame: From the first administration of the trial drug until end of the trial, up to 31 days.

Results and safety

Results posted to the registry on 28 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 1015550 (C-14)	6	6

Primary outcome: Percentage of the Amount of [14C]-Radioactivity Excreted Among the Administered Single Oral Dose of [14-C] BI 1015550-EQ in Urine (Feurine, 0-tz), Faeces (Fefaeces, 0-tz) and Vomit (Fevomit, 0-tz)

Time frame: From Day -1 or Day 1 - 2 hours (h) before drug administration until release criteria for radioactivity recovery had been met, up to Day 30-31. See also description section.. Geometric mean (Geometric Coefficient of Variation). Unit: Percentage of administered dose

Measure	BI 1015550 (C-14) n = 6
urine	36.4 (11.8)
faeces	58.0 (12.7)

Population analysed: Treated set (TS): The TS set included all subjects who were entered and treated with the single dose of the trial drug. There was no occurrence of vomit among the participants therefore number of participants analyzed is zero for fevomit,0-tz.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: "All-Cause Mortality", "Serious Adverse Events", and "Other Adverse Events": From the first administration of the trial drug until end of the trial, up to 31 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 1015550 (C-14)	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42563128Jappar D, Wu J, Burkard U, Sharma A, Coeck C, Zoz D, Yu Y. Pharmacokinetics and Safety of Nerandomilast in Healthy Volunteers. Eur J Drug Metab Pharmacokinet. 2026 Aug 6. doi: 10.1007/s13318-026-01027-9. Online ahead of print.
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: https://www.mystudywindow.com/msw/datasharing

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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 1015550 (C-14) in people with Healthy, run by Boehringer Ingelheim at 1 site in Netherlands.

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 10 inclusion and 9 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 28 Nov 2025. 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 Netherlands. 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 28 Nov 2025). 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 the Amount of [14C]-Radioactivity Excreted Among the Administered Single Oral Dose of [14-C] BI 1015550-EQ in Urine (Feurine, 0-tz), Faeces (Fefaeces, 0-tz) and Vomit (Fevomit, 0-tz) (time frame: From Day -1 or Day 1 - 2 hours (h) before drug administration until release criteria for radioactivity recovery had been met, up to Day 30-31. See also description section.). 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 NCT04771286, which also lists 1 linked publication.

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 28 Nov 2025.