HealthyPhase 1NCT01638598

Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers

A Phase 1 study testing Test drug in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers 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?: Test drug
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteSouth Korea
Study dates: Jul 2012to Aug 2012
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 based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan <5 years, and have parents and grandparents who were all born in Japan Chinese; ethnic 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
Age within the range of 20 to 45 years
Body mass index within the range of 18.5 and 25 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Who cannot join

Any finding of the medical examination (including Blood Pressure, Pulse Rate, ECG and Safety laboratory) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts.

Show all 21Show fewer

Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy/hypersensitivity to the study drug or its excipients)
Intake of drugs with a long half-life (more than 24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to administration
Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval (based on the knowledge at the time of protocol preparation) within 10 days prior to administration
Participation in another trial with an investigational drug administration within 2 months prior to administration
Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
Inability to refrain from smoking on trial days
Alcohol abuse (more than 30 g/day)
Drug abuse
Blood donation (more than 100 mL within 4 weeks prior to administration)
Any laboratory value outside the reference range that is of clinical relevance
Inability to comply with dietary regimen of trial site
A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval more than 450 ms), heart rate outside 45 to 90 bpm, or any other relevant ECG findings at screening
A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of long QT Syndrome)
Subjects considered unsuitable for inclusion by the investigator, e.g. because considered not able to understand and comply with study requirements, or have any condition which in the opinion of the investigator would not allow safe participation in the study

Trial locations and contacts

1 site in 1 country.

South Korea1 site

1310.3.8201 Boehringer Ingelheim Investigational Site
Seoul

Other trials in South Korea

About this study

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers (Placebo-controlled, Randomised and Double-blind Within Dose Groups)

Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers

Conditions: Healthy
Being tested: matching placebo, Test drug

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

matching placeboDrug
matching placebo in each dose level
Test drugDrug
BI 1021958
matching placeboDrug
matching placebo in each dose level
Test drugDrug
BI 1021958
Test drugDrug
BI 1021958
Test drugDrug
BI 1021958
Test drugDrug
BI 1021958
matching placeboDrug
matching placebo in each dose level
matching placeboDrug
matching placebo in each dose level
matching placeboDrug
matching placebo in each dose level

Study groups in NCT01638598
Study group	Role	What they receive
BI 1021958 dose group 1	Experimental	subject to receive a tablet containing dose group 1 BI 1021958 single dose Receives: Drug: Test drug; Drug: matching placebo
BI 1021958 dose group 2	Experimental	subject to receive a tablet containing dose group 2 BI 1021958 single dose Receives: Drug: matching placebo; Drug: Test drug
BI 1021958 dose group 3	Experimental	subject to receive a tablet containing dose group 3 BI 1021958 single dose Receives: Drug: Test drug; Drug: matching placebo
BI 1021958 dose group 4	Experimental	subject to receive a tablet containing dose group 4 BI 1021958 single dose Receives: Drug: matching placebo; Drug: Test drug
BI 1021958 dose group 5	Experimental	subject to receive a tablet containing dose group 5 BI 1021958 single dose Receives: Drug: Test drug; Drug: matching placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The number (%) of subjects with related adverse events.
Measured: up to 17 days postdose

Secondary outcomes (5)

AUC0-inf (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity)
Measured: up to day 4 postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)
Measured: up to day 4 postdose
AUC0-12 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 12 h)
Measured: up to day 4 postdose
Cmax (maximum measured concentration of BI 1021958 in plasma)
Measured: up to day 4 postdose
AUC0-24 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 24 h)
Measured: up to day 4 postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Aug 2012

First posted12 Jul 2012 (estimated)
Study startJul 2012
Primary completionAug 2012
Study completionAug 2012

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: Double blind
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01638598
Sponsor's protocol ID: 1310.3
Status last verified: Oct 2013
First submitted: 2 Jul 2012
Last updated: 1 Nov 2013
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1021958 in Healthy Chinese and Japanese Male Volunteers (Placebo-controlled, Randomised and Double-blind Within Dose Groups)
ClinicalTrials.gov ID: NCT01638598
Acronym / sponsor ID: 1310.3
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 12 Jul 2012 (estimated)
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.

Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 5

Arm	Type	Receives
BI 1021958 dose group 1	Experimental	Drug: Test drug, Drug: matching placebosubject to receive a tablet containing dose group 1 BI 1021958 single dose
BI 1021958 dose group 2	Experimental	Drug: matching placebo, Drug: Test drugsubject to receive a tablet containing dose group 2 BI 1021958 single dose
BI 1021958 dose group 3	Experimental	Drug: Test drug, Drug: matching placebosubject to receive a tablet containing dose group 3 BI 1021958 single dose
BI 1021958 dose group 4	Experimental	Drug: matching placebo, Drug: Test drugsubject to receive a tablet containing dose group 4 BI 1021958 single dose
BI 1021958 dose group 5	Experimental	Drug: Test drug, Drug: matching placebosubject to receive a tablet containing dose group 5 BI 1021958 single dose

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy males based upon a complete medical history, including a physical examination, vital signs (blood pressure, pulse rate), 12-lead ECG, and clinical laboratory tests
Chinese ethnicity, Japanese ethnicity according to the following criteria Japanese; born in Japan, be a current Japanese passport holder, have lived outside of Japan <5 years, and have parents and grandparents who were all born in Japan Chinese; ethnic 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
Age within the range of 20 to 45 years
Body mass index within the range of 18.5 and 25 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Key exclusion criteria (21 listed)

Any finding of the medical examination (including Blood Pressure, Pulse Rate, ECG and Safety laboratory) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological 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
matching placebomatching placebo in each dose level	Drug	BI 1021958 dose group 2
Test drugBI 1021958	Drug	BI 1021958 dose group 3
matching placebomatching placebo in each dose level	Drug	BI 1021958 dose group 4
Test drugBI 1021958	Drug	BI 1021958 dose group 2
Test drugBI 1021958	Drug	BI 1021958 dose group 5
Test drugBI 1021958	Drug	BI 1021958 dose group 1
Test drugBI 1021958	Drug	BI 1021958 dose group 4
matching placebomatching placebo in each dose level	Drug	BI 1021958 dose group 1
matching placebomatching placebo in each dose level	Drug	BI 1021958 dose group 3
matching placebomatching placebo in each dose level	Drug	BI 1021958 dose group 5

Primary outcome

The number (%) of subjects with related adverse events.
Time frame: up to 17 days postdose

5 secondary outcomes

AUC0-inf (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to day 4 postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)
Time frame: up to day 4 postdose
AUC0-12 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 12 h)
Time frame: up to day 4 postdose
Cmax (maximum measured concentration of BI 1021958 in plasma)
Time frame: up to day 4 postdose
AUC0-24 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 24 h)
Time frame: up to day 4 postdose

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 2013.

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Recruiting
Developing a Support Application for Food Pantries (SAFPAS) to Improve Client Access to Healthy Foods & Enhance Emergency Preparedness
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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 Test drug in people with Healthy, run by Boehringer Ingelheim at 1 site in South Korea.

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 5 inclusion and 21 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 2013. 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 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. 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 number (%) of subjects with related adverse events. (time frame: up to 17 days postdose). 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 NCT01638598.

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 2013; AzTrials last refreshed its copy on 8 Nov 2026.