Status:
COMPLETED
Pharmacokinetics of BI 409306 After a High Fat, High Caloric Meal and After a Single Oral Dose Given at Bed Time in Healthy Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
To evaluate the effect of food on the pharmacokinetics of BI 409306 and to investigate the pharmacokinetics of BI 409306 when given at bed time.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy male and female volunteers
- Age 18 (incl.) to 50 (incl.) years
- Body mass index (BMI) range: 18.5 (incl.) to 29.9 (incl.) kg/m2
- Exclusion criteria:
- Any evidence of a clinically relevant concomitant disease
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- 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, fainting spells or blackouts, occurrence of syncopes, brady- or tachycardia in the anamnesis.
- Positive pregnancy test
- No adequate contraception during the study and until 1 month of study completion, i.e. intrauterine device (IUD), sexual abstinence (for at least 1 month prior to enrolment), or surgical sterilisation (incl. hysterectomy). Females, who are not surgically sterile will be asked to additionally use barrier contraception methods (e.g. condom, diaphragm with spermicide)
Exclusion
Key Trial Info
Start Date :
September 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02222168
Start Date
September 4 2014
End Date
October 31 2014
Last Update
July 31 2024
Active Locations (1)
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1
1289.22.1 Boehringer Ingelheim Investigational Site
Berlin, Germany