Hepatic InsufficiencyPhase 1NCT05731895

A Study to Test How Iclepertin is Taken up in the Blood of People With and Without Liver Problems

A Phase 1 study testing Iclepertin in people with Hepatic Insufficiency, run by Boehringer Ingelheim at 1 site in Germany.

Completed

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

Official record

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Trial summary

This study is open to people with and without liver problems. People can join the study if they are 18 to 79 years of age and have a body mass index (BMI) between 18.5 and 35 kg/m2. Iclepertin (also called BI 425809) is a medicine that is being developed to treat diseases of the brain. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Hepatic Insufficiency
What is being tested?: Iclepertin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteGermany
Study dates: 8 Mar 2023to 11 Dec 2023
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 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or female participants
Age 18-79 years (inclusive)
Body Mass Index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m2) (inclusive)
Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Male participants are not required to use contraception
Women of childbearing potential are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 30 days after trial completion.

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The following methods of contraception are considered adequate for female participants of childbearing potential:
Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
Sexually abstinent (true abstinence, in line with the preferred and usual lifestyle of the subject) - -A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant.
Female participants are not considered to be of childbearing potential if they are either surgically sterilized (including hysterectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of follicle-stimulating hormone (FSH) above 40 unit per liter (U/L) and oestradiol below 30 nanogram per liter (ng/L) is confirmatory).
Inclusion criteria applying only to participants with impaired hepatic function:
Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child Pugh B (score 7-9 points)
further inclusion criteria apply
Inclusion criteria applying only to participants with normal hepatic function:
Individually matched to participants with hepatic impairment according to sex, age, and weight
further inclusion criteria apply

Who cannot join

Any evidence of a concomitant disease assessed as clinically relevant by the investigator
For diabetics only: uncontrolled diabetes mellitus with a glycated hemoglobin (HbA1c) > 9
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics (PK) of the trial medication (except appendectomy or simple hernia repair)
Diseases of the Central Nervous System (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder or history of suicide attempts)
History of relevant orthostatic hypotension, fainting spells, or blackouts
Relevant chronic or acute infections

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further exclusion criteria apply
Exclusion criteria applying only to participants with hepatic impairment:
A marked prolongation of the time from the start of the Q wave to the end of the T wave (QT)/ Corrected QT (QTc) interval (such as QTc Fridericia (QTcF) intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other clinically relevant electrocardiogram (ECG) finding at screening
further exclusion criteria apply
Exclusion criteria applying only to participants with normal hepatic function:
Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator
further exclusion criteria apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

CRS Clinical Research Services Kiel GmbH
Kiel, 24105

Other trials in Germany

About this study

Official title: Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individualmatched Design Trial)

This study is open to people with and without liver problems. People can join the study if they are 18 to 79 years of age and have a body mass index (BMI) between 18.5 and 35 kg/m2.

Iclepertin (also called BI 425809) is a medicine that is being developed to treat diseases of the brain. The purpose of this study is to find out whether having liver problems influences how iclepertin is taken up in the body. All participants take iclepertin once as a tablet.

Participants are in the study for 2 to 3 weeks. During the first part of the study, they stay at the study site for 4 nights. Afterwards, there are 5 visits to the study site and 1 call. The site staff measures the amount of iclepertin in the blood. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions: Hepatic Insufficiency
Being tested: Iclepertin
Medical subject headings: Hepatic Insufficiency

What participants receive

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

IclepertinDrug
Also called BI 425809
A single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours.

Study groups in NCT05731895
Study group	Role	What they receive
Iclepertin - Control - normal hepatic function	Experimental	Participants with normal hepatic function were individual-matched (matching criteria: gender, age within ± 10 years, and weight within ± 15%) to participants with mild or moderate hepatic function (Child-Pugh A or B) and received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours. Each control participant with normal hepatic function could be matched to 1 participant in 1 or both groups of participants with hepatic impairment. Receives: Drug: Iclepertin
Iclepertin - Child-Pugh A - Mild hepatic impairment	Experimental	Participants with mild hepatic function (Child-Pugh A) received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours. Receives: Drug: Iclepertin
Iclepertin - Child-Pugh B - Moderate hepatic impairment	Experimental	Participants with Moderate hepatic function (Child-Pugh B) received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours. Receives: Drug: Iclepertin

What is being measured

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

Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including the fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'.
Measured: Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.
Maximum Measured Concentration of Iclepertin in Plasma (Cmax)
Maximum measured concentration of iclepertin in plasma (Cmax). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including the fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'.
Measured: Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.

Secondary outcomes (1)

Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including the fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'.
Measured: Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.

Timeline

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

8 Mar 202311 Dec 2023

First posted16 Feb 2023
Study start8 Mar 2023
Primary completion11 Dec 2023
Study completion11 Dec 2023

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 Hepatic InsufficiencyStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05731895
Sponsor's protocol ID: 1346-0048
Other IDs: 2022-003418-35
Status last verified: Apr 2026
First submitted: 8 Feb 2023
Last updated: 24 Apr 2026
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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Publications

Choi H, Madari S, Daalman E, English BA, Halabi A, Hohl K, Shatillo Y, Weidinger N, Desch M. The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies. Drugs R D. 2026 Mar;26(1):83-100. doi: 10.1007/s40268-026-00537-w. Epub 2026 Mar 28.
PubMed 41903096

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 Hepatic Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individualmatched Design Trial)
ClinicalTrials.gov ID: NCT05731895
Acronym / sponsor ID: 1346-0048
Conditions: Hepatic Insufficiency
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 8 Mar 2023 (actual)
Primary completion: 11 Dec 2023 (actual)
Study completion: 11 Dec 2023 (actual)
First posted: 16 Feb 2023 (actual)
Results: Posted 30 Mar 2026

Clinical summary

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

This study is open to people with and without liver problems. People can join the study if they are 18 to 79 years of age and have a body mass index (BMI) between 18.5 and 35 kg/m2.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Iclepertin - Control - normal hepatic function	Experimental	Drug: IclepertinParticipants with normal hepatic function were individual-matched (matching criteria: gender, age within ± 10 years, and weight within ± 15%) to participants with mild or moderate hepatic function (Child-Pugh A or B) and received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours. Each control participant with normal hepatic function could be matched to 1 participant in 1 or both groups of participants with hepatic impairment.
Iclepertin - Child-Pugh A - Mild hepatic impairment	Experimental	Drug: IclepertinParticipants with mild hepatic function (Child-Pugh A) received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours.
Iclepertin - Child-Pugh B - Moderate hepatic impairment	Experimental	Drug: IclepertinParticipants with Moderate hepatic function (Child-Pugh B) received a single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Male or female participants
Age 18-79 years (inclusive)
Body Mass Index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m2) (inclusive)
Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Male participants are not required to use contraception

Key exclusion criteria (13 listed)

Any evidence of a concomitant disease assessed as clinically relevant by the investigator
For diabetics only: uncontrolled diabetes mellitus with a glycated hemoglobin (HbA1c) > 9
Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics (PK) of the trial medication (except appendectomy or simple hernia repair)
Diseases of the Central Nervous System (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder or history of suicide attempts)
History of relevant orthostatic hypotension, fainting spells, or blackouts

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
IclepertinAlso: BI 425809A single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours.	Drug	Iclepertin - Child-Pugh A - Mild hepatic impairment, Iclepertin - Child-Pugh B - Moderate hepatic impairment, Iclepertin - Control - normal hepatic function

Primary outcome

Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.
Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including the fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'.
Maximum Measured Concentration of Iclepertin in Plasma (Cmax)
Time frame: Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.
Maximum measured concentration of iclepertin in plasma (Cmax). Geometric least square mean (adjusted geometric mean) and adjusted geometric standard error were calculated using an analysis of variance (ANOVA) model on the logarithmic scale including the fixed effect 'degree of hepatic impairment' and the random effect 'matched pair'.

1 secondary outcome

Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.

Results and safety

Results posted to the registry on 30 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iclepertin - Control - Normal Hepatic Function	13	13
Iclepertin - Child-Pugh A - Mild Hepatic Impairment	8	8
Iclepertin - Child-Pugh B - Moderate Hepatic Impairment	8	8

Primary outcome: Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.. Geometric least squares mean (Standard Error). Unit: hour*nanomole/Liter

Measure	Iclepertin - Child-Pugh A - Control - Normal Hepatic Function n = 8	Iclepertin - Child-Pugh A - Mild Hepatic Impairment n = 8	Iclepertin - Child-Pugh B - Control - Normal Hepatic Function n = 8	Iclepertin - Child-Pugh B - Moderate Hepatic Impairment n = 8
Value	5329.59 (na)	4812.01 (na)	4090.68 (na)	5264.70 (na)

Iclepertin - Child-Pugh A - Control - Normal Hepatic Function vs Iclepertin - Child-Pugh A - Mild Hepatic Impairment: Ratio of adjusted geometric means [%]: 90.29 (90% CI 73.41 to 111.04)
Iclepertin - Child-Pugh B - Control - Normal Hepatic Function vs Iclepertin - Child-Pugh B - Moderate Hepatic Impairment: Ratio of adjusted geometric means [%]: 128.70 (90% CI 104.01 to 159.25)

Population analysed: Pharmacokinetic parameter analysis set (PKS): All participants who were treated with at least 1 dose of trial drug and who provided at least 1 primary or secondary Pharmacokinetic (PK) endpoint and were not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non evaluability.

Primary outcome: Maximum Measured Concentration of Iclepertin in Plasma (Cmax)

Measure	Child-Pugh A - Control n = 8	Iclepertin - Child-Pugh A - Mild Hepatic Impairment n = 8	Child-Pugh B - Control n = 8	Iclepertin - Child-Pugh B - Moderate Hepatic Impairment n = 8
Value	121.00 (na)	123.48 (na)	112.71 (na)	92.26 (na)

Child-Pugh A - Control vs Iclepertin - Child-Pugh A - Mild Hepatic Impairment: Ratio of adjusted geometric means [%]: 102.05 (90% CI 82.41 to 126.38)
Child-Pugh B - Control vs Iclepertin - Child-Pugh B - Moderate Hepatic Impairment: Ratio of adjusted geometric means [%]: 81.86 (90% CI 67.23 to 99.67)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events: Up to 11 days following drug administration. All-cause mortality: Up to 19 days following drug administration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iclepertin - Child-Pugh A - Control - Normal Hepatic Function	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Iclepertin - Child-Pugh A - Mild Hepatic Impairment	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Iclepertin - Child-Pugh B - Control - Normal Hepatic Function	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Iclepertin - Child-Pugh B - Moderate Hepatic Impairment	0 of 8 (0%)	1 of 8 (12.5%)	0 of 8

Limitations and caveats (from the sponsor): Small number (8 per group) of participants.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41903096Choi H, Madari S, Daalman E, English BA, Halabi A, Hohl K, Shatillo Y, Weidinger N, Desch M. The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies. Drugs R D. 2026 Mar;26(1):83-100. doi: 10.1007/s40268-026-00537-w. Epub 2026 Mar 28.
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. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

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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 Iclepertin in people with Hepatic Insufficiency, run by Boehringer Ingelheim at 1 site in Germany.

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 18 inclusion and 13 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 24 Apr 2026. 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 Germany. 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 30 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve of Iclepertin in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) (time frame: Within 2 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144 and 192 hours following drug administration.). The study lists 2 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 NCT05731895, 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 24 Apr 2026.