Clinical trial NCT02260076: Safety of Total Daily Doses of Polyethylene Glycol (PEG) 400 Administered Orally to Healthy Male Human Subjects
Official title: Safety of Total Daily Doses of 5, 10, 15 and 20 mL PEG 400 Administered Orally to Healthy Male Human Subjects Once (QD) or Twice (BID) for 14 Days. A Single Center, Multiple Rising Dose Study, Placebo Controlled, Double-blinded at Each Dose Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses


Eligibility criteria: 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

Primary outcomes:
measure: Number of subjects with clinically relevant findings in vital signs
timeFrame: up to 7 days after last drug administration
measure: Number of subjects with clinically relevant findings in laboratory tests
timeFrame: up to 7 days after last drug administration
measure: Number of subjects with clinically relevant findings in 12-lead ECG
timeFrame: up to 7 days after last drug administration
measure: Number of subjects with clinically relevant findings in physical examination
timeFrame: up to 7 days after last drug administration
measure: Number of subjects with adverse events
timeFrame: up to 7 days after last drug administration
measure: Assessment of global tolerability by the investigator on a 4-point rating scale
timeFrame: up to 7 days after last drug administration
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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