Assessment of Exposure of BI 409306 in Cerebrospinal Fluid (CSF) Relative to Plasma as Well as to Evaluation of the Effect of Different Doses of BI 409306 on the cGMP (Cyclic Guanosine Monophosphate) Levels in CSF in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01493570
First received: December 12, 2011
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

Due to the exploratory nature of this trial, there is no primary objective in a confirmatory sense. The study aims

- to evaluate the effect of different doses of BI 409306 on biomarker and to assess the exposure of BI 409306


Condition Intervention Phase
Healthy
Drug: BI 409306
Drug: BI 409306 Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled Parallel-group Proof of Mechanism Study to Assess the Pharmacokinetics and to Evaluate the Pharmacodynamic Effect of Different Single Oral Doses of BI 409306 in Healthy Male Volunteers

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Maximum change from baseline (calculated as ratio) of biomarker [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Cmax ratio of BI 409306 in different media [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum measured biomarker concentration [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Time from dosing to maximum measured in biomarker concentration [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Cmax (maximum measured BI 409306 concentration in different media) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured BI 409306 concentration in different media) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 409306 low dose
Film-coated tablet
Drug: BI 409306
Low dose film-coated tablet
Experimental: BI 409306 low dose
Film-coated tablet
Drug: BI 409306
Low dose film-coated tablet
Experimental: BI 409306 medium dose
Film-coated tablet
Drug: BI 409306
Medium dose film-coated tablet
Experimental: BI 409306 high dose
Film-coated tablet
Drug: BI 409306
High dose film-coated tablet
Experimental: Placebo
Film-coated tablet
Drug: BI 409306 Placebo
Film-coated tablet

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy males according to the following criteria:

    Based upon a complete medical history, including the physical examination, vital signs after 10 minutes in supine position (BP (blood pressure), PR (pulse rate), BT (body temperature)), 12-lead ECG (electrocardiogram), clinical laboratory tests

  2. Age =21 and Age =50 years
  3. BMI =18.5 and BMI =29.9 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion criteria:

  1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and considered by the investigator as clinical relevant
  2. Abnormal values for PT (Prothrombin Time) (, aPTT (Partial Thromboplastin Time) and trombocytes considered by the investigator as clinically relevant
  3. Any evidence of a clinically relevant concomitant disease
  4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  5. Surgery of the gastrointestinal tract (except appendectomy)
  6. Diseases of the central nervous system (included but not limited to any kind of seizures, stroke or psychiatric disorders)
  7. History of relevant orthostatic hypotension, fainting spells or blackouts.
  8. Chronic or relevant acute infections
  9. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  10. Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration
  11. 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 or during the trial
  12. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  13. Smoker, who consume more than 5 cigarettes per day
  14. Inability to refrain from smoking on trial days
  15. Alcohol abuse (more than 20 g/day): 2 units/day (14 units/week)
  16. Drug abuse
  17. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  18. Excessive physical activities (within one week prior to administration or during the trial)
  19. Any laboratory value outside the reference range that is of clinical relevance
  20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTcF interval >450 ms)
  21. Inability to understand and to comply with protocol requirements and restrictions and dietary regimen of trial site
  22. of additional risk factors for TdP (Torsades de points) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
  23. Male subjects who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until three month after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female (intra-uterine device with spermicide, hormonal contraceptive since at least two months)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493570

Locations
Belgium
1289.3.1 Boehringer Ingelheim Investigational Site
Antwerpen, Belgium
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01493570     History of Changes
Other Study ID Numbers: 1289.3, 2011-003749-16
Study First Received: December 12, 2011
Last Updated: October 31, 2013
Health Authority: Belgium: Federal Agency for Medicinal and Health Products

ClinicalTrials.gov processed this record on July 28, 2014