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

October 31, 2013 updated by: Boehringer Ingelheim

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • 1310.3.8201 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria:

  1. 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
  2. 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
  3. Age within the range of 20 to 45 years
  4. Body mass index within the range of 18.5 and 25 kg/m2
  5. Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation.

Exclusion criteria:

  1. Any finding of the medical examination (including Blood Pressure, Pulse Rate, ECG and Safety laboratory) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Surgery of the gastrointestinal tract (except appendectomy)
  5. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  6. History of relevant orthostatic hypotension, fainting spells or blackouts.
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy/hypersensitivity to the study drug or its excipients)
  9. 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
  10. 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
  11. Participation in another trial with an investigational drug administration within 2 months prior to administration
  12. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
  13. Inability to refrain from smoking on trial days
  14. Alcohol abuse (more than 30 g/day)
  15. Drug abuse
  16. Blood donation (more than 100 mL within 4 weeks prior to administration)
  17. Any laboratory value outside the reference range that is of clinical relevance
  18. Inability to comply with dietary regimen of trial site
  19. 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
  20. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of long QT Syndrome)
  21. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BI 1021958 dose group 1
subject to receive a tablet containing dose group 1 BI 1021958 single dose
Drug: matching placebo
matching placebo in each dose level
Drug: Test drug
BI 1021958
Experimental: BI 1021958 dose group 2
subject to receive a tablet containing dose group 2 BI 1021958 single dose
Drug: matching placebo
matching placebo in each dose level
Drug: Test drug
BI 1021958
Experimental: BI 1021958 dose group 3
subject to receive a tablet containing dose group 3 BI 1021958 single dose
Drug: matching placebo
matching placebo in each dose level
Drug: Test drug
BI 1021958
Experimental: BI 1021958 dose group 4
subject to receive a tablet containing dose group 4 BI 1021958 single dose
Drug: matching placebo
matching placebo in each dose level
Drug: Test drug
BI 1021958
Experimental: BI 1021958 dose group 5
subject to receive a tablet containing dose group 5 BI 1021958 single dose
Drug: matching placebo
matching placebo in each dose level
Drug: Test drug
BI 1021958

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The number (%) of subjects with related adverse events.
Time Frame: up to 17 days postdose
up to 17 days postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
up to day 4 postdose
Cmax (maximum measured concentration of BI 1021958 in plasma)
Time Frame: up to day 4 postdose
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
up to day 4 postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 12, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1310.3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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