Healthy
Conditions
Brief summary
To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses
Interventions
DRUGPEG 400
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male subjects as determined by results of screening * Signed written informed consent in accordance with good clinical practice (GCP) and local legislation * Age ≥ 18 and ≤ 55 years * Broca ≥ - 20 % and ≤ + 20 %
Exclusion criteria
* Any finding of the medical examination (including blood pressure, pulse rate and electrocardiogram \[ECG\]) deviating from normal and of clinical relevance * History of current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders, including a clinical history of viral hepatitis, or serological evidence of active Hepatitis B or Hepatitis C infection * History of orthostatic hypotension, fainting spells and blackouts * Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * Chronic or relevant acute infections * History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * Intake of drugs with a long half-life (\> 24 hours) within one month prior to administration * Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial * Participation in another trial with an investigational drug within one month prior to administration or during the trial * Smoker (\> 10 cigarettes or three cigars or three pipes/day) or inability to refrain from smoking 10 hours before the morning dose and one hour before afternoon/evening dose and one hour after any dose * Alcohol abuse (\> 60 g/day) * Drug abuse * Blood donation within one month prior to administration or during the trial * Excessive physical activities within five days prior to administration or during the trial * Any laboratory value outside the clinically accepted reference range and of clinical relevance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with clinically relevant findings in vital signs | up to 7 days after last drug administration | blood pressure, pulse rate |
| Number of subjects with clinically relevant findings in laboratory tests | up to 7 days after last drug administration | — |
| Number of subjects with clinically relevant findings in 12-lead ECG | up to 7 days after last drug administration | — |
| Number of subjects with clinically relevant findings in physical examination | up to 7 days after last drug administration | — |
| Number of subjects with adverse events | up to 7 days after last drug administration | — |
| Assessment of global tolerability by the investigator on a 4-point rating scale | up to 7 days after last drug administration | — |
Outcome results
None listed