HealthyPhase 1NCT02652416
Safety, Tolerability and Pharmacokinetics of BI 1026706 in Healthy Chinese and Japanese Male Volunteers
A Phase 1 study testing BI 1026706 in people with Healthy, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses (SRD) followed by multiple rising doses (MRD) 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 1026706
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- 16 Sep 2016to 9 Dec 2016
- 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 investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Chinese ethnicity 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 were all born in Japan
- Age of 20 to 45 years (incl.) - BMI of 18.5 to 25 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study 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 30 days after trial completion:
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- 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
Who cannot join
- Any finding in the medical examination (including BP, PR or 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 T-SPOT) test. Subjects with a positive QuantiFERON TB-Gold (or T-SPOT) test may participate in the study if further work up (according to local practice/guidelines) establishes conclusively that the subject has no evidence of active tuberculosis. If presence of latent tuberculosis is established, then treatment must have been initiated and maintained according to local country guidelines.
- 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 10 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 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)
- 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
- Male patients who do not agree to minimize the risk of female partners becoming pregnant from at least 30 days before the first administration of trial medication and until 30 days after trial completion.
- 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
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1026706 in Healthy Chinese and Japanese Male Volunteers (Randomised, Double-blind, Placebo-controlled Trial)
Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)
- Conditions
- Healthy
- Being tested
- BI 1026706, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1026706Drug
oral administration
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| SRD part (low dose) | Experimental | Chinese, Japanese both Receives: Drug: BI 1026706 |
| SRD part (medium dose) | Experimental | Chinese, Japanese both Receives: Drug: BI 1026706 |
| SRD part (high dose) | Experimental | Chinese, Japanese both Receives: Drug: BI 1026706 |
| MD part (high dose) | Experimental | Chinese, Japanese both Receives: Drug: BI 1026706 |
| Placebo (SRD part) | Experimental | placebo Receives: Drug: Placebo |
| Placebo (MD part) | Placebo comparator | placebo Receives: Drug: Placebo |
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)
The percentage of subjects with drug-related AEs indicate the safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses of 25 mg, 50 mg, and 100 mg, followed by multiple doses of 100 mg bid.
Measured: From first drug administration to 4 days after last drug intake, up to 19 days.
Secondary outcomes (8)
Cmax
This outcome measure presents maximum measured concentration of the analyte [BI 1026706] in plasma.
TS-SRD part: This subject set included all subjects who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the SRD part. All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.
Measured: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
Tmax
This outcome measure presents time from dosing to maximum measured concentration of the analyte [BI 1026706] in plasma.
All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.
Measured: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
AUC0-12
This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma over the time interval from 0 extrapolated to 12 hours (AUC0-12).
All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.
Measured: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
AUC0-infinity
This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma over the time interval from 0 extrapolated to infinity.
All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.
Measured: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
t1/2
This outcome measure presents terminal half-life of the analyte [BI 1026706] in plasma.
All subjects in the TS-SRD part who provided at least 1 PK parameter in the SRD part that was not excluded were to be considered for this endpoint.
Measured: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
Cmax,ss
This outcome measure presents maximum measured concentration of the analyte [BI 1026706] in plasma at steady state over a uniform dosing interval tau.
TS-MD part: This subject set included all subjects from the 100 mg group in the SRD part who were dispensed BI 1026706 and were documented to have taken at least 1 dose of investigational treatment in the MD part. All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint.
Measured: 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.
Tmax,ss
This outcome measure presents time from last dosing to maximum concentration of the analyte [BI 1026706] in plasma at steady state (tmax,ss) .
All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint.
Measured: 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.
AUC Tau,ss
This outcome measure presents area under the concentration-time curve of the analyte [BI 1026706] in plasma at steady state over a uniform dosing interval tau (AUC tau,ss).
All subjects in the TS-MD part who provide at least 1 PK parameter in the MD part that was not excluded were to be considered for this endpoint.
Measured: 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study start16 Sep 2016
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652416
- Sponsor's protocol ID
- 1320.23
- Status last verified
- Apr 2019
- First submitted
- 8 Jan 2016
- Last updated
- 11 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses and Multiple Oral Doses of BI 1026706 in Healthy Chinese and Japanese Male Volunteers (Randomised, Double-blind, Placebo-controlled Trial)
- ClinicalTrials.gov ID
- NCT02652416
- Acronym / sponsor ID
- 1320.23
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2016 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 11 Jan 2016 (estimated)
- Results
- Posted 11 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses (SRD) followed by multiple rising doses (MRD)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SRD part (low dose) | Experimental | Drug: BI 1026706Chinese, Japanese both |
| SRD part (medium dose) | Experimental | Drug: BI 1026706Chinese, Japanese both |
| SRD part (high dose) | Experimental | Drug: BI 1026706Chinese, Japanese both |
| MD part (high dose) | Experimental | Drug: BI 1026706Chinese, Japanese both |
| Placebo (SRD part) | Experimental | Drug: Placeboplacebo |
| Placebo (MD part) | Placebo comparator | Drug: Placeboplacebo |
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 investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
- Chinese ethnicity 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 were all born in Japan
- Age of 20 to 45 years (incl.) - BMI of 18.5 to 25 kg/m2 (incl.)
Key exclusion criteria (25 listed)
- Any finding in the medical examination (including BP, PR or 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 1026706oral administration | Drug | MD part (high dose), SRD part (high dose), SRD part (low dose), SRD part (medium dose) |
| Placeboplacebo | Drug | Placebo (MD part), Placebo (SRD part) |
Primary outcome
Percentage of Subjects With Drug-related Adverse Events (AEs)
Time frame: From first drug administration to 4 days after last drug intake, up to 19 days.
The percentage of subjects with drug-related AEs indicate the safety and tolerability of BI 1026706 in healthy Chinese and Japanese male subjects following oral administration of single rising doses of 25 mg, 50 mg, and 100 mg, followed by multiple doses of 100 mg bid.
8 secondary outcomes
Cmax
Time frame: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
Tmax
Time frame: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
AUC0-12
Time frame: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
AUC0-infinity
Time frame: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
t1/2
Time frame: -1:30 (hours:minutes) before drug administration and 0:15, 0:30, 0:45, 1:00, 1:30, 2:00, 2:30, 3:00, 4:00, 6:00, 8:00, 10:00, 12:00, 24:00, 34:00, 48:00 and 72:00 (hours:minutes) after drug administration.
Cmax,ss
Time frame: 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.
Tmax,ss
Time frame: 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.
AUC Tau,ss
Time frame: 23:55, 47:55, 71:55, 95:55, 119:55, 167:55, 239:55, 263:55, 264:15, 264:30, 264:45, 265:00, 265:30, 266:00, 266:30, 267:00, 268:00, 270:00, 272:00, 274:00, 276:00, 288:00, 298:00, 312:00 and 336:00 (hours:minutes) after drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
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 1026706 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 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 11 Jul 2019. 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 11 Jul 2019). 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 first drug administration to 4 days after last drug intake, up to 19 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 11 Jul 2019.