HealthyPhase 1NCT03804671

A Study in Healthy Men to Measure the Amount of BI 730357 in the Blood When Taken as a Tablet

A Phase 1 study testing BI 730357 and BI 730357 mixed with [C-14] BI 730357 BS 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.

Official record

Search all trials

Trial summary

To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with [C-14]BI 730357 BS administered as intravenous microtracer 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 730357 and BI 730357 mixed with [C-14] BI 730357 BS
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteNetherlands
Study dates: 31 Jan 2019to 26 Mar 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 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 Electrocardiogram (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
Further inclusion criteria apply

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 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 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
Clinically significant gastrointestinal (including known or suspected inflammatory bowel disease), hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
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: Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 730357 Administered as an Oral Dose With an Intravenous Microtracer Dose of BI 730357 BS (C-14) in Healthy Male Volunteers

To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with [C-14]BI 730357 BS administered as intravenous microtracer

Conditions: Healthy
Being tested: BI 730357, BI 730357 mixed with [C-14] BI 730357 BS

What participants receive

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

BI 730357Drug
Oral dose
BI 730357 mixed with [C-14] BI 730357 BSDrug
Intravenous dose

Study groups in NCT03804671
Study group	Role	What they receive
All Subjects	Experimental	Test treatment T followed by Reference treatment R Receives: Drug: BI 730357; Drug: BI 730357 mixed with [C-14] BI 730357 BS

What is being measured

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

Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized).
Area under the concentration-time curve of the analyte over the time interval from 0 to infinity (AUC0-∞). For both arms results are presented in millimole (mmol) * hours (h) / Litre (L) / kilogram (kg). This was achieved by transforming the reference arm to the treatment arm and normalizing the results according to the respective dose.
Measured: Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion.

Timeline

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

31 Jan 201926 Mar 2019

First posted15 Jan 2019
Study start31 Jan 2019
Primary completion26 Mar 2019
Study completion26 Mar 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.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03804671
Sponsor's protocol ID: 1407-0033
Other IDs: 2018-003103-19, 2018
Status last verified: Jul 2023
First submitted: 14 Jan 2019
Last updated: 25 Jul 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/

Publications

Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
PubMed 36919398

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

Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of Pharmacokinetics and Absolute Oral Bioavailability of BI 730357 Administered as an Oral Dose With an Intravenous Microtracer Dose of BI 730357 BS (C-14) in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT03804671
Acronym / sponsor ID: 1407-0033
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 31 Jan 2019 (actual)
Primary completion: 26 Mar 2019 (actual)
Study completion: 26 Mar 2019 (actual)
First posted: 15 Jan 2019 (actual)
Results: Posted 25 Jul 2023

Clinical summary

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

To investigate the absolute oral bioavailability of BI 730357 administered as tablet compared with [C-14]BI 730357 BS administered as intravenous microtracer

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All Subjects	Experimental	Drug: BI 730357, Drug: BI 730357 mixed with [C-14] BI 730357 BSTest treatment T followed by Reference treatment R

Who may qualify

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

Key inclusion criteria (5 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 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
Further inclusion criteria apply

Key exclusion criteria (6 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 139 mmHg, diastolic blood pressure outside the range of 45 to 89 mmHg, or pulse rate outside the range of 40 to 100 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
Clinically significant gastrointestinal (including known or suspected inflammatory bowel disease), 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 730357Oral dose	Drug	All Subjects
BI 730357 mixed with [C-14] BI 730357 BSIntravenous dose	Drug	All Subjects

Primary outcome

Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized).
Time frame: Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion.
Area under the concentration-time curve of the analyte over the time interval from 0 to infinity (AUC0-∞). For both arms results are presented in millimole (mmol) * hours (h) / Litre (L) / kilogram (kg). This was achieved by transforming the reference arm to the treatment arm and normalizing the results according to the respective dose.

Results and safety

Results posted to the registry on 25 Jul 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
All Subjects	6	6

Primary outcome: Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized).

Time frame: Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion.. Geometric mean (Standard Error). Unit: mmol*h/L/kg

Measure	BI 730357 50mg Tablet (T) n = 6	BI 730357 BS (C-14) 100 µg Infusion (R) n = 6
Value	NA (NA)	NA (NA)

BI 730357 50mg Tablet (T) vs BI 730357 BS (C-14) 100 µg Infusion (R): Ratio of the geometric means (T/R) %: 70.32 (90% CI 56.69 to 87.23)

Population analysed: Pharmacokinetic parameter analysis set (PKS): This set included all subjects in the treated set (TS) who provided at least one pharmacokinetic (PK) endpoint that was defined as primary and was not excluded due to a protocol deviation relevant to the evaluation of PK or due to PK non-evaluability.

Adverse events

Time frame: From the first administration of trial drug to the end of residual effect period up to 7 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Subjects	0 of 6 (0%)	3 of 6 (50%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36919398Ooi QX, Kristoffersson A, Korell J, Flack M, L Plan E, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023 Jun;12(6):758-769. doi: 10.1002/psp4.12948. Epub 2023 May 1.
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/

Related trials for Healthy

Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy

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 730357 and BI 730357 mixed with [C-14] BI 730357 BS 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 5 inclusion and 6 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 Jul 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 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 25 Jul 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?

Area Under the Concentration-time Curve of BI 730357 Over the Time Interval From 0 to Infinity (Dose Normalized). (time frame: Test treatment T: within 3h before and 1,1.5,2,2.5,3.5,5,7,12,24,72,120,168h after oral administration. Reference treatment R: within 3h before and 5,10,15,30,45 minutes and 1.25,2.25,3.75,5.75,10.75,22.75,70.75,118.75,166.75h after start of iv infusion.). 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 NCT03804671, 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 25 Jul 2023.