Safety of Total Daily Doses of Polyethylene Glycol (PEG) 400 Administered Orally to Healthy Male Human Subjects

Study Overview
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Brief Summary
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To assess the safety and tolerance of 5 mL to 20 mL PEG 400 in multiple rising doses

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: PEG 400
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG 400<br>multiple rising doses | Drug: PEG 400<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with clinically relevant findings in vital signs | blood pressure, pulse rate | up to 7 days after last drug administration | 
| 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 |