Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Healthy Male Volunteers

July 9, 2014 updated by: Boehringer Ingelheim

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of BI 1181181 in Young Healthy Male Volunteers (Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)

To assess the reduction of ß-amyloid levels in cerebrospinal fluid and plasma and to evaluate pharmacokinetics, safety and tolerability following single oral doses of BI 1181181.

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.
36

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

  • Belgium
      • Antwerpen, Belgium
        • 1344.20.32001 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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion criteria:

  1. Healthy males according to the investigator´s assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
  2. Age 18 to 50 years (incl.)
  3. BMI 18.5 to 29.9 kg/m2 (incl.)
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

  1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and judged clinically relevant by the investigator
  2. Repeated measurement of systolic blood pressure < 90 mmHg and >= 140 mmHg at screening in supine position
  3. Repeated measurement of diastolic blood pressure < 55 and >= 90 mmHg at screening in supine position
  4. Repeated measurement of pulse rate < 40 bpm and > 90 bpm at screening
  5. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
  6. Any evidence of a concomitant disease judged clinically relevant by the investigator
  7. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  8. Surgery of the gastrointestinal tract that could interfere with kinetics of the trial drug
  9. Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
  10. History of relevant orthostatic hypotension, fainting spells, or blackouts
  11. Chronic or relevant acute infections
  12. Positive testing on infectious diseases
  13. History of relevant allergy/hypersensitivity (including allergy to the trial medication or its excipients)
  14. Intake of drugs with a long half-life (>24 hours) within 30 days or less than 10 halflives of the respective drug prior to administration of trial medication
  15. Within 10 days prior to administration of trial medication, use of drugs that might reasonably influence the results of the trial
  16. Participation in another trial with investigational drug administration within 60 days prior to administration of trial medication
  17. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
  18. Inability to refrain from smoking on trial days
  19. Alcohol abuse (consumption of more than 40 g per day)
  20. Drug abuse
  21. Positive testing in the alcohol breath test or the drug screening test
  22. Blood donation (more than 100 mL within 30 days prior to administration of trial medication or during the trial)
  23. Intention to perform excessive physical activities within one week prior to administration of trial medication or during the trial
  24. Inability to comply with dietary regimen of trial site
  25. At screening, a marked baseline prolongation of QT/QTc interval (such as repeated demonstration of a QTcF interval >450 ms) or any other relevant ECG finding
  26. A history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome)
  27. Abnormal parameters for thyroid hormones (T3, T4, TSH), coagulation parameters (partial thromboplastin time (aPTT), prothrombin time (PT) and fibrinogen (retests prior inclusion are allowed))
  28. Subject is assessed by the investigator as unsuitable for inclusion, 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
  29. Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two month after the trial completion. Acceptable methods of contraception comprise barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive for at least two month prior trial participation)
  30. History of retinopathy
  31. Any history or present disease of the central nervous system, the spinal cord or the spinal column, which could provoke complications with procedure of the lumbar catheterization/intrathecal punction
  32. Signs of intracranial overpressure as determined by funduscopy

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: Single Group 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: 1 BI 1181181 low dose
tablet
Drug: BI 1181181 low dose
one tablet
Experimental: BI 1181181 high dose
tablet
Drug: BI 1181181 high dose
two tablet
Experimental: Placebo
tablet
Drug: Placebo
tablet

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
%-change from baseline of Aß1-40 in cerebrospinal fluid at the end of the dosing interval (i.e., 24 hrs post dose) (PoM)
Time Frame: up to 24 h
up to 24 h

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-tz (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid over the time interval from 0 to the last quantifiable data point)
Time Frame: up to 72 h
up to 72 h
Cmax (maximum measured concentration of the analyte in plasma and cerebrospinal fluid)
Time Frame: up to 72 h
up to 72 h
AUC0-infinity (area under the concentration-time curve of the analyte in plasma and cerebrospinal fluid (if possible) over the time interval from 0 extrapolated to infinity)
Time Frame: up to 72 h
up to 72 h

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.
April 1, 2014

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.
June 1, 2014

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.
June 1, 2014

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).
April 1, 2014

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.
April 3, 2014

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.
April 8, 2014

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.
July 10, 2014

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.
July 9, 2014

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.
July 1, 2014

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.
  • 1344.20
  • 2013-004563-32 (EudraCT Number: EudraCT)

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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