Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01505894
First received: January 5, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.

The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers


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: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 409306 Film-coated Tablets Given Orally q.d. or Bid for 14 Days in Young Healthy and Elderly Healthy Male/Female Volunteers (Randomised, Double-blind, Placebo Controlled Within Dose Groups Phase I Study)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant findings in vital signs [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically relevant findings in physical examination [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of tolerability by investigator (global assessment) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Suicidality assessment [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Color discrimination test [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Visual acuity test [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Ophthalmological examination [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • tmax (time from dosing to maximum measured concentration of the analyte in plasma) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • AUC0-24 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 24 hours) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • AUC0-12 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 12 hours) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 83
Study Start Date: January 2012
Study Completion Date: July 2012
Primary Completion Date: July 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 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: BI 409306 high dose
Film-coated tablet
Drug: BI 409306
High dose film-coated tablet
Placebo Comparator: Placebo
Film-coated tablet
Drug: BI 409306 Placebo
Placebo film-coated tablet

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests
  2. Age >21 and Age <50 years for young healthy volunteers or Age >65 and Age <80 years for elderly healthy volunteers
  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 Good Clinical Practice (GCP) and the local legislation.
  5. For female subjects: Female subjects must be surgically sterilized or postmenopausal. Surgical sterilization or hysterectomy must have occurred at least 6 months prior to screening. Menopausal women must have no regular menstrual bleeding for at least 2 years prior to screening.

Exclusion criteria:

  1. Any finding of the medical examination (including BP, PR and ECG) 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 (including but not limited to any kind of seizures, stroke or psychiatric disorders)
  6. History or evidence of relevant orthostatic reaction (drop in systolic blood pressure (SBP) >20 mm Hg and increase in heart rate > 30 bpm after 2 minutes standing relative to supine data), fainting spells or blackouts.
  7. Chronic or relevant acute infections
  8. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  9. Intake of any drugs within 14 days or 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 or during the trial
  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 or during the trial
  11. Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
  12. Smoker (> 5 cigarettes or > 1 cigars or > 1 pipes/day)
  13. Inability to refrain from smoking on trial days
  14. Alcohol abuse (more than 20 g/day)
  15. Drug abuse
  16. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
  17. Excessive physical activities (within one week prior to administration or during the trial)
  18. Any laboratory value outside the reference range that is of clinical relevance in the judgment of investigator
  19. Inability to comply with dietary regimen of trial site
  20. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc F interval >430 ms in males and >450 ms in females);
  21. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01505894

Locations
Germany
1289.2.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01505894     History of Changes
Other Study ID Numbers: 1289.2, 2011-002369-39
Study First Received: January 5, 2012
Last Updated: October 31, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on October 29, 2014