HealthyPhase 1NCT04665700
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 764198 Are Tolerated
A Phase 1 study testing BI 764198 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
The main objectives of this trial are to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single dose and multiple rising doses per day over 14 days. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BI 764198
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteJapan
- Study dates
- 6 Feb 2021to 16 Oct 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 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 (BP, PR), 12-lead ECG, and clinical laboratory tests
- Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
- Age of 20 to 45 years at screening (inclusive)
- BMI of 18.5 to 25.0 kg/m2 (inclusive)
- Signed and dated written informed consent prior to admission to the trial, in accordance with GCP and local legislation
- Willingness to comply with contraception requirements. Subjects who are sexually active must use adequate contraception methods throughout the trial and until three months after the last administration of trial medication. Adequate methods are:
Show all 9Show fewer
- A vasectomy performed at least 1 year prior to screening and with medical assessment of the surgical success or
- Surgical sterilisation, including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy, of the subject's female partner or
- The use of condoms, if the female partner uses an adequate contraception method in addition, e.g., intrauterine device (IUD), or hormonal contraception, such as implants and injectables*, combined with oral or vaginal contraceptives, that started at least 2 months prior to first drug administration, or barrier method, e.g., diaphragm with spermicide* * hormonal contraception via implants and injectables, and diaphragm with spermicide are not approved in Japan Unprotected sexual intercourse with a pregnant partner is not allowed throughout the trial and until three months after the last administration of trial medication.
Who cannot join
- Any finding in the medical examination (including BP, PR or 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 50 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)- 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.
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single and Multiple Rising Doses of BI 764198 in Japanese Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled Within Dose Groups, Parallel Group Design)
The main objectives of this trial are to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single dose and multiple rising doses per day over 14 days.
Secondary objectives are the exploration of pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing.
- Conditions
- Healthy
- Being tested
- BI 764198, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 764198Drug
BI 764198
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| BI 764198 Single dose part | Experimental | Not described Receives: Drug: BI 764198 |
| BI 764198 Multiple dose low | Experimental | Not described Receives: Drug: BI 764198 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| BI 764198 Multiple dose medium | Experimental | Not described Receives: Drug: BI 764198 |
| BI 764198 Multiple dose high | Experimental | Not described Receives: Drug: BI 764198 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage [%] of subjects with drug-related adverse events
Measured: Up to 34 days
Secondary outcomes (4)
After single dose: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to 6 days
After single dose: Cmax (maximum measured concentration of the analyte in plasma)
Measured: Up to 6 days
After the last dose of multiple dose segment: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Up to 22 days
After the last dose of multiple dose segment: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start6 Feb 2021
- Primary completion16 Oct 2021
- Study completion16 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial consists of a single dose part and a multiple rising dose (MRD) part. The first dose group is conducted in the single dose part and the second dose group onwards are conducted in the MRD part.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665700
- Sponsor's protocol ID
- 1434-0003
- Status last verified
- Oct 2021
- First submitted
- 7 Dec 2020
- Last updated
- 1 Nov 2021
- Results posted
- No
- 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
Yonemura T, Sarashina A, Tachibana Y, Retlich S, Soleymanlou N. A randomized, Phase I study of the safety, tolerability, and pharmacokinetics of BI 764198, a transient receptor potential channel 6 (TRPC6) inhibitor, in healthy Japanese men. Expert Opin Investig Drugs. 2025 May;34(5):425-433. doi: 10.1080/13543784.2025.2510664. Epub 2025 Jun 3.
PubMed 40402558
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single and Multiple Rising Doses of BI 764198 in Japanese Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled Within Dose Groups, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT04665700
- Acronym / sponsor ID
- 1434-0003
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2021 (actual)
- Primary completion
- 16 Oct 2021 (actual)
- Study completion
- 16 Oct 2021 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this trial are to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single dose and multiple rising doses per day over 14 days.
Secondary objectives are the exploration of pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- This trial consists of a single dose part and a multiple rising dose (MRD) part. The first dose group is conducted in the single dose part and the second dose group onwards are conducted in the MRD part.
| Arm | Type | Receives |
|---|---|---|
| BI 764198 Single dose part | Experimental | Drug: BI 764198 |
| BI 764198 Multiple dose low | Experimental | Drug: BI 764198 |
| Placebo | Placebo comparator | Drug: Placebo |
| BI 764198 Multiple dose medium | Experimental | Drug: BI 764198 |
| BI 764198 Multiple dose high | Experimental | Drug: BI 764198 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male subjects according to the assessment of the investigator, as based on a complete medical history, including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
- Age of 20 to 45 years at screening (inclusive)
- BMI of 18.5 to 25.0 kg/m2 (inclusive)
- Signed and dated written informed consent prior to admission to the trial, in accordance with GCP and local legislation
Key exclusion criteria (7 listed)
- Any finding in the medical examination (including BP, PR or 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 50 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 764198BI 764198 | Drug | BI 764198 Multiple dose high, BI 764198 Multiple dose low, BI 764198 Multiple dose medium, BI 764198 Single dose part |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The percentage [%] of subjects with drug-related adverse events
Time frame: Up to 34 days
4 secondary outcomes
After single dose: AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 6 days
After single dose: Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 6 days
After the last dose of multiple dose segment: AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Up to 22 days
After the last dose of multiple dose segment: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Up to 22 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Derived from this study: PubMed 40402558Yonemura T, Sarashina A, Tachibana Y, Retlich S, Soleymanlou N. A randomized, Phase I study of the safety, tolerability, and pharmacokinetics of BI 764198, a transient receptor potential channel 6 (TRPC6) inhibitor, in healthy Japanese men. Expert Opin Investig Drugs. 2025 May;34(5):425-433. doi: 10.1080/13543784.2025.2510664. Epub 2025 Jun 3.
- 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
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 764198 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
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 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage [%] of subjects with drug-related adverse events (time frame: Up to 34 days). 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 NCT04665700, 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 1 Nov 2021.