Status:
TERMINATED
Multiple Rising Dose of BI 1181181 Given Orally in Young Healthy Male and Elderly Healthy Male/Female Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
The primary objective of the current study is to investigate the safety and tolerability of BI 1181181 in healthy young male and elderly male and female volunteers following oral administration of rep...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male or female subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests.
- Age of 18 to 50 years (incl.) for young healthy volunteers or of 65 to 80 years (incl.) for elderly healthy volunteers.
- BMI of 18.5 to 29.9 kg/m2 (incl.)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation.
- Exclusion criteria:
- Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- Any evidence of a concomitant disease judged as clinically relevant by the investigator
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication (except appendectomy)
- Diseases of the central nervous system (such as epilepsy), other neurological disorders or psychiatric disorders
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02254161
Start Date
November 1 2014
End Date
February 1 2015
Last Update
August 31 2018
Active Locations (1)
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1
1344.2.1 Boehringer Ingelheim Investigational Site
Berlin, Germany