Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
Brief Summary
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 pharm...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Age \>21 and Age \<50 years for young healthy volunteers or Age \>65 and Age \<80 years for elderly healthy volunteers
- BMI \>18.5 and BMI \<29.9 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
- 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:
- Any finding of the medical examination (including BP, PR and ECG) 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 (including but not limited to any kind of seizures, stroke or psychiatric disorders)
- 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.
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- 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
- 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
- Participation in another trial with an investigational drug within four weeks prior to administration or during the trial
- Smoker (\> 5 cigarettes or \> 1 cigars or \> 1 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 20 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance in the judgment of investigator
- Inability to comply with dietary regimen of trial site
- 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);
- A history of additional risk factors for Torsades de points (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome);
Exclusion
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT01505894
Start Date
January 1 2012
End Date
July 1 2012
Last Update
March 8 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
1289.2.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany