HealthyPhase 1NCT03259464
This Study Tests BI 685509 in Healthy Chinese and Japanese Men; the Study Tests How Different Doses of BI 685509 Are Taken up in the Body and How Well They Are Tolerated
A Phase 1 study testing BI 685509 in people with Healthy, run by Boehringer Ingelheim at 2 sites in 2 countries.
Trial summary
The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 685509 in healthy Chinese and Japanese… 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 685509
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 4 Sep 2017to 26 May 2018
- 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 investigator's assessment, 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
- Chinese or Japanese ethnicity, according to the following criteria:
- Chinese; born in China or ethnic Chinese born outside of China, and a descendent of 4 ethnic Chinese grandparents who were all born in China
- Japanese; born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
- Age of 20 to 45 years (incl.)
- Body mass index (BMI) range: ≥18.5 and <25.0 kg/m2
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- Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
- Male subjects who agree to minimize the risk of female partners becoming pregnant by fulfilling any of the following criteria starting from at least 30 days before the first administration of trial medication and until 90 days after trial completion:
- Use of adequate contraception, e.g. any of the following methods plus condom: combined oral contraceptives, intrauterine device
- Vasectomised (vasectomy at least 1 year prior to enrolment)
- Surgically sterilised (including hysterectomy) female partner
- Sexually abstinent
Who cannot join
- Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (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
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- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Chronic or relevant acute infections including HIV, viral hepatitis and (or) tuberculosis or evidence of tuberculosis infection as defined by a positive QuantiFERON TB-Gold (or TSPOT) test. Subjects with a positive QuantiFERON TB-Gold (or T-SPOT) test will not participate in the study. The HBV carriers and subjects with history of HB (including the subjects with only HBs antibody positive [negative for both HBs antigen and HBc antibody] and without HB vaccination) will not be allowed to participate in this trial.
- History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
- Intake of biologic agents other than current study medication or drugs considered likely to interfere with the safe conduct of the study
- Within 30 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial or that might prolong the QT/QTc interval
- Participation in another trial (including bioequivalence trial) with an investigational drug within 90 days or 5 half-lives (whichever is greater) prior to planned administration of trial medication
- Smoker (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 30 g per day)
- Drug abuse or positive drug screening
- Blood donation of more than 200 mL within 30 days or 400 mL within 12 weeks prior to administration of trial medication or intended donation during the trial
- Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (such as QTc intervals that are repeatedly greater than 450 ms) or any other relevant ECG finding at screening
- A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
- 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 45 to 90 bpm
- Have received any live bacterial or live viral vaccination in the 12 weeks prior to the date of screening. Subjects must agree not to receive a live bacterial or live viral vaccination during the study and up to 12 months after the last administration of study drug
- Have received Bacille Calmette-Guerin (BCG) vaccination in the 12 months prior to the date of screening. Subjects must agree not to receive BCG vaccination during the study and up to 12 months after the last administration of study drug
- Subject is assessed as unsuitable for inclusion by the investigator, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 685509 in Healthy Chinese and Japanese Male Volunteers (Randomised, Single-blind, Placebo-controlled Trial)
The primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses.
Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 685509 in healthy Chinese and Japanese subjects.
- Conditions
- Healthy
- Being tested
- BI 685509, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 685509Drug
3 sequential dose groups
PlaceboDrug
3 sequential dose groups
| Study group | Role | What they receive |
|---|---|---|
| BI 685509 | Experimental | Chinese \& Japanese subjects Receives: Drug: BI 685509 |
| Placebo | Placebo comparator | Chinese \& Japanese subjects Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number [N (%)] of subjects with drug-related Adverse Events (AEs)
Measured: up to day 35
Secondary outcomes (4)
After the first dose:AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h)
Measured: up to 24 hours
After the first dose:Cmax (maximum measured concentration of the analyte in plasma)
Measured: up to 72 hours
After the drug administration on Day 10 and Day 17 of DGs 1-2: AUCtau,ss (area under the concentration-time curve of the analyte in plasma over the dosing interval tau at steady state) [AUCtau,ss will be AUC0-12,ss for b.i.d. and AUC0-24,ss for q.d.]
Measured: Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours
After the drug administration on Day 10 and Day 17 of DGs 1-2: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Measured: Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start4 Sep 2017
- Primary completion26 May 2018
- Study completion26 May 2018
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
- 72 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
- NCT03259464
- Sponsor's protocol ID
- 1366-0013
- Status last verified
- Jul 2018
- First submitted
- 22 Aug 2017
- Last updated
- 5 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 685509 in Healthy Chinese and Japanese Male Volunteers (Randomised, Single-blind, Placebo-controlled Trial)
- ClinicalTrials.gov ID
- NCT03259464
- Acronym / sponsor ID
- 1366-0013
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 26 May 2018 (actual)
- Study completion
- 26 May 2018 (actual)
- First posted
- 23 Aug 2017 (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 primary objective of this trial is to investigate the safety and tolerability of BI 685509 in healthy male subjects following oral administration of multiple rising doses.
Secondary objectives are the exploration of the pharmacokinetics (PK) and pharmacodynamics (PD) of BI 685509 in healthy Chinese and Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 685509 | Experimental | Drug: BI 685509Chinese \& Japanese subjects |
| Placebo | Placebo comparator | Drug: PlaceboChinese \& Japanese subjects |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy male subjects according to the investigator's assessment, 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
- Chinese or Japanese ethnicity, according to the following criteria:
- Age of 20 to 45 years (incl.)
- Body mass index (BMI) range: ≥18.5 and <25.0 kg/m2
- Signed and dated written informed consent by date of Visit 1 in accordance with Good Clinical Practice (GCP) and local legislation.
Key exclusion criteria (25 listed)
- Any finding in the medical examination (including Blood pressure (BP), Pulse rate (PR) or Electrocardiogram (ECG)) is deviating from normal and judged as clinically relevant by the investigator
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy and 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 |
|---|---|---|
| BI 6855093 sequential dose groups | Drug | BI 685509 |
| Placebo3 sequential dose groups | Drug | Placebo |
Primary outcome
Number [N (%)] of subjects with drug-related Adverse Events (AEs)
Time frame: up to day 35
4 secondary outcomes
After the first dose:AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h)
Time frame: up to 24 hours
After the first dose:Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours
After the drug administration on Day 10 and Day 17 of DGs 1-2: AUCtau,ss (area under the concentration-time curve of the analyte in plasma over the dosing interval tau at steady state) [AUCtau,ss will be AUC0-12,ss for b.i.d. and AUC0-24,ss for q.d.]
Time frame: Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours
After the drug administration on Day 10 and Day 17 of DGs 1-2: Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)
Time frame: Dose Group (DG) 1: up to 240 hours & up to 408 hours DG2: up to 240 hours & up to 396 hours
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 5 Jul 2018.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 685509 in people with Healthy, run by Boehringer Ingelheim at 2 sites in 2 countries.
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 12 inclusion and 25 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 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan, South Korea. 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?
Number [N (%)] of subjects with drug-related Adverse Events (AEs) (time frame: up to day 35). 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 5 Jul 2018.