HealthyPhase 1NCT04384081
A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2
A Phase 1 study testing BI 456906 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
Main objectives are to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male subject with BMI 23-40 kg/m2 and to determine a dose escalation scheme for future studies. 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 456906
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jun 2020to 20 Jan 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 males according to the assessment of the investigator, based on a complete medical history, a physical examination, vital signs (BP, PR), 12-lead 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, and have parents and grandparents who are Japanese
- Age of 20 to 45 years (inclusive) at screening visit.
- BMI of 23.0 to 40.0 kg/m2 (inclusive) with a minimum absolute body weight of 65 kg at screening visit and a stable body weight (defined as no more than 5% change) 3 months prior to screening visit.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
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- 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, 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 subjects female partner
- HbA1c < 6.5% at screening visit
Who cannot join
- Exposure to any glucagon-like peptide 1 receptor (GLP-1R) agonist (including combination products) within twelve months prior to screening visit, or any previous exposure to BI 456906, or history of relevant allergy or hypersensitivity (including allergy, intolerability or lack of efficacy to trial medication or drugs that belong to the GLP-1R agonist class)
- Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 6 months after screening visit, e.g. hip replacement
- Any evidence of a concomitant disease, baseline condition, or medical history assessed as clinically relevant by the investigator including:
- Repeated measurement of supine blood pressure (BP) ≥160/95 mmHg, or pulse rate (PR) >90 bpm after 5 minutes of resting at screening visit.
- Renal artery stenosis or evidence of labile blood pressure including symptomatic hypotension, or history of relevant orthostatic hypotension, fainting spells, or blackouts.
- A marked baseline prolongation of Q wave to T wave (QT)/QTc (corrected) interval (such as QTc intervals that are greater than 450 ms at screening or an increase of 30 ms versus screening or any other relevant ECG finding at screening (e.g., type 2 second-degree atrioventricular (AV) block (Type Mobitz II) or third-degree AV block) and heart rhythm disturbances (e.g., bradycardia with baseline heart rate (HR) <45 bpm (in the absence of medications that lower the heart rate), or tachyarrhythmia or ventricular tachycardia).
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- Family history of long QT-syndrome, use of prescription or over-the-counter medications known to significantly prolong the QT or QTc interval at screening.
- A history of pancreatitis or a history of/current increase of Amylase/Lipase > 1.5- fold Upper limit of normal (ULN)
- Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening visit, except appropriately treated basal cell carcinoma of the skin, personal or family history of medullary thyroid carcinoma or history of multiple endocrine neoplasia syndrome type 2
- Any clinical condition that requires continuous pharmacotherapy during the trial. Pharmacotherapy that potentially induce a change in body weight (for example anti-hyperglycemic, anti-depressant, diuretics, steroids, insulin, anti-psychotics) need to be stopped 6 months prior to screening visit
- Cholecystectomy and/or prior surgery of the GI tract (including bariatric surgery) that could interfere with body weight or the pharmacokinetics (PK) of the trial medication or auxiliary medicinal products of the trial [paracetamol (acetaminophen)] except appendectomy and 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
- Chronic or relevant acute infections including viral hepatitis, human immunodeficiency virus (HIV) and/or syphilis.
- History of relevant allergy or hypersensitivity (including allergy to trial medication or its excipients)
- History of congestive heart failure New York Heart Association (NYHA) class IIIV or cardiovascular abnormalities such as ventricular or supraventricular arrhythmias. History of symptomatic ventricular tachycardia, or history of type 2 second-degree AV block (Type Mobitz II) or third-degree AV block.
- Any of the following conditions or procedures within the last six months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft (e.g. carotid bypass, peripheral vascular diseases bypass), percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischaemic attack, cerebrovascular accident (stroke) or decompensated congestive heart failure.
- Any lifetime history of suicidal behavior (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
- Any suicidal ideation of type 2 to 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 12 months (i.e. active suicidal thought without method, intent or plan; active suicidal thought with method but without intent or plan; active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent and plan).
- Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered within 60 days or 5 half-lives (whichever is longer) prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
- Current smokers (defined as more than 10 cigarettes or 3 cigars or 3 pipes per day)
- Inability to refrain from smoking on specified trial days
- Alcohol abuse (consumption of more than 24 g per day) Further exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-blinded, Randomized, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Dose Escalation Schemes of BI 456906 in Healthy Japanese Male Subject With BMI 23-40 kg/m2
Main objectives are to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male subject with BMI 23-40 kg/m2 and to determine a dose escalation scheme for future studies.
- Conditions
- Healthy
- Being tested
- BI 456906, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 456906Drug
Solution for injection
PlaceboDrug
Solution for injection
| Study group | Role | What they receive |
|---|---|---|
| Dose group 1 | Experimental | Not described Receives: Drug: BI 456906 |
| Dose group 2 | Experimental | Not described Receives: Drug: BI 456906 |
| Dose group 3 | Experimental | Not described Receives: Drug: BI 456906 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative percentage (%) of subjects withdrawn from up-titration by dose escalation scheme.
Measured: up to 113 days
Secondary outcomes (2)
AUC0-168 (area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to 168h)
Measured: up to 113 days
Cmax (maximum measured concentration of BI 456906 in plasma) after first dose
Measured: up to 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Jun 2020
- Primary completion17 Nov 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 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
- NCT04384081
- Sponsor's protocol ID
- 1404-0021
- Status last verified
- Jan 2021
- First submitted
- 11 May 2020
- Last updated
- 26 Jan 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: http://trials.boehringer-ingelheim.com/
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-blinded, Randomized, Multiple Dose, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Different Dose Escalation Schemes of BI 456906 in Healthy Japanese Male Subject With BMI 23-40 kg/m2
- ClinicalTrials.gov ID
- NCT04384081
- Acronym / sponsor ID
- 1404-0021
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 12 May 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.
Main objectives are to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of different dose escalation schemes of BI 456906 in healthy Japanese male subject with BMI 23-40 kg/m2 and to determine a dose escalation scheme for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose group 1 | Experimental | Drug: BI 456906 |
| Dose group 2 | Experimental | Drug: BI 456906 |
| Dose group 3 | Experimental | Drug: BI 456906 |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males according to the assessment of the investigator, based on a complete medical history, a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests at screening visit
- Japanese ethnicity, according to the following criteria:
- Age of 20 to 45 years (inclusive) at screening visit.
- BMI of 23.0 to 40.0 kg/m2 (inclusive) with a minimum absolute body weight of 65 kg at screening visit and a stable body weight (defined as no more than 5% change) 3 months prior to screening visit.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Key exclusion criteria (23 listed)
- Exposure to any glucagon-like peptide 1 receptor (GLP-1R) agonist (including combination products) within twelve months prior to screening visit, or any previous exposure to BI 456906, or history of relevant allergy or hypersensitivity (including allergy, intolerability or lack of efficacy to trial medication or drugs that belong to the GLP-1R agonist class)
- Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to randomization or planned within 6 months after screening visit, e.g. hip replacement
- Any evidence of a concomitant disease, baseline condition, or medical history assessed as clinically relevant by the investigator including:
- Use of drugs within 30 days prior to administration of trial medication if that might reasonably influence the results of the trial (including drugs that cause QT/QTc interval prolongation)
- Participation in another trial where an investigational drug has been administered within 60 days or 5 half-lives (whichever is longer) prior to planned administration of trial medication, or current participation in another trial involving administration of investigational drug
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 456906Solution for injection | Drug | Dose group 1, Dose group 2, Dose group 3 |
| PlaceboSolution for injection | Drug | Placebo group |
Primary outcome
Cumulative percentage (%) of subjects withdrawn from up-titration by dose escalation scheme.
Time frame: up to 113 days
2 secondary outcomes
AUC0-168 (area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to 168h)
Time frame: up to 113 days
Cmax (maximum measured concentration of BI 456906 in plasma) after first dose
Time frame: up to 113 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 26 Jan 2021.
- 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/
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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 456906 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 23 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 26 Jan 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?
Cumulative percentage (%) of subjects withdrawn from up-titration by dose escalation scheme. (time frame: up to 113 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 26 Jan 2021.