HealthyPhase 1NCT04964453
A Study in Healthy Men to Test How BI 474121 is Tolerated
A Phase 1 study testing BI 474121 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
Safety, tolerability, and pharmacokinetics of BI 474121 will be assessed in healthy Japanese male using single rising oral doses in order to provide the basis for an ongoing clinical development of BI 474121 for the treatment of cognitive impairment in patients with Alzheimer's Disease and schizophrenia. 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 474121
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jul 2021to 16 Nov 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 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 (blood pressure (BP), pulse rate (PR)) including body temperature, 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit
- Japanese ethnicity, according to the following criteria:
- born in Japan, have lived outside of Japan <10 years,
- have parents and grandparents who are Japanese
- Age of 20 to 45 years (inclusive) at screening visit
- Body mass index (BMI) of 18.5 to 25.0 kilogram per square meter (kg/m2) (inclusive) at screening visit
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- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication
- Use of adequate contraception by any of the following methods plus condom: intrauterine device, combined oral contraceptives that started at least 2 months prior to the first drug administration.
- Vasectomized (vasectomy at least 1 year prior to enrolment)
- Surgical sterilization (including bilateral tubal occlusion, hysterectomy or bilateral oophorectomy) of the subject's female partner.
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 at screening visit
- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 millimetre of mercury (mmHg), or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening visit
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
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- Chronic or relevant acute infections including viral hepatitis, human immunodeficiency virus (HIV) and/or syphilis.
- History of cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 474121 in Healthy Japanese Male Subjects (Doubleblind, Randomised, Placebo-controlled, Parallel Group Design)
Safety, tolerability, and pharmacokinetics of BI 474121 will be assessed in healthy Japanese male using single rising oral doses in order to provide the basis for an ongoing clinical development of BI 474121 for the treatment of cognitive impairment in patients with Alzheimer's Disease and schizophrenia.
- Conditions
- Healthy
- Being tested
- Placebo, BI 474121
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
BI 474121Drug
Healthy subjects were given a single dose of BI 474121 as a uncoated tablet(s) taken orally with 240 milliliter of water after an overnight fast of at least 10 hours.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Healthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. Receives: Drug: Placebo |
| 2.5 mg BI 474121 | Experimental | Healthy subjects were given a single dose of 2.5 milligram (mg) of BI 474121 as a single (2.5 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. Receives: Drug: BI 474121 |
| 5 mg BI 474121 | Experimental | Healthy subjects were given a single dose of 5 milligram (mg) of BI 474121 as two (2.5 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. Receives: Drug: BI 474121 |
| 10 mg BI 474121 | Experimental | Healthy subjects were given a single dose of 10 milligram (mg) of BI 474121 as a single (10 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. Receives: Drug: BI 474121 |
| 20 mg BI 474121 | Experimental | Healthy subjects were given a single dose of 20 milligram (mg) of BI 474121 as two (10 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. Receives: Drug: BI 474121 |
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 (AEs)
Percentage of subjects with investigator-defined drug-related adverse events (AEs).
Measured: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days.
Secondary outcomes (2)
Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of BI 474121 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Measured: Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following drug administration.
Maximum Measured Concentration of BI 474121 in Plasma (Cmax)
Maximum measured concentration of BI 474121 in plasma (Cmax).
Measured: Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 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.
- First posted16 Jul 2021
- Study start21 Jul 2021
- Primary completion11 Nov 2021
- Study completion16 Nov 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.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT04964453
- Sponsor's protocol ID
- 1411-0012
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2021
- Last updated
- 7 Mar 2024
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. 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 474121 in Healthy Japanese Male Subjects (Doubleblind, Randomised, Placebo-controlled, Parallel Group Design)
- ClinicalTrials.gov ID
- NCT04964453
- Acronym / sponsor ID
- 1411-0012
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 7 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety, tolerability, and pharmacokinetics of BI 474121 will be assessed in healthy Japanese male using single rising oral doses in order to provide the basis for an ongoing clinical development of BI 474121 for the treatment of cognitive impairment in patients with Alzheimer's Disease and schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboHealthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| 2.5 mg BI 474121 | Experimental | Drug: BI 474121Healthy subjects were given a single dose of 2.5 milligram (mg) of BI 474121 as a single (2.5 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| 5 mg BI 474121 | Experimental | Drug: BI 474121Healthy subjects were given a single dose of 5 milligram (mg) of BI 474121 as two (2.5 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| 10 mg BI 474121 | Experimental | Drug: BI 474121Healthy subjects were given a single dose of 10 milligram (mg) of BI 474121 as a single (10 mg) uncoated tablet taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
| 20 mg BI 474121 | Experimental | Drug: BI 474121Healthy subjects were given a single dose of 20 milligram (mg) of BI 474121 as two (10 mg) uncoated tablets taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 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)) including body temperature, 12-lead electrocardiogram (ECG), and clinical laboratory tests at screening visit
- Japanese ethnicity, according to the following criteria:
- Body mass index (BMI) of 18.5 to 25.0 kilogram per square meter (kg/m2) (inclusive) at screening visit
- Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation
- Subjects who agree to minimize the risk of making their partner pregnant by fulfilling any of the following criteria starting from the first administration of trial medication until 90 days after last administration of trial medication
Key exclusion criteria (11 listed)
- Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator at screening visit
- Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 millimetre of mercury (mmHg), or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening visit
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance at screening visit
- Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- History of cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
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 |
|---|---|---|
| PlaceboHealthy subjects were given a single dose of placebo tablet(s) matched to the active treatment, subjects receiving placebo were equally distributed across dose groups. Tablet(s) were taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. | Drug | Placebo |
| BI 474121Healthy subjects were given a single dose of BI 474121 as a uncoated tablet(s) taken orally with 240 milliliter of water after an overnight fast of at least 10 hours. | Drug | 10 mg BI 474121, 2.5 mg BI 474121, 20 mg BI 474121, 5 mg BI 474121 |
Primary outcome
Percentage of Subjects With Drug-related Adverse Events (AEs)
Time frame: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days.
Percentage of subjects with investigator-defined drug-related adverse events (AEs).
2 secondary outcomes
Area Under the Concentration-time Curve of BI 474121 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following drug administration.
Maximum Measured Concentration of BI 474121 in Plasma (Cmax)
Time frame: Within 3 hours before and 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72 and 96 hours following drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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: 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 474121 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 11 inclusion and 11 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 7 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 7 Mar 2024). 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 (AEs) (time frame: From the time of first administration of study medication until 168 hours (7 days) after time of administration, up to 8 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.