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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PEG 400; Drug: Placebo

• Registration Number: NCT02260076
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2002-03
• Status Verified: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-08
• Last Update Submitted: 2014-10-08
• Study First Posted: 2014-10-09
• Last Update Posted: 2014-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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 %

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEG 400	PEG 400	multiple rising doses
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 physical examination	up to 7 days after last drug administration
Number of subjects with adverse events	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
Assessment of global tolerability by the investigator on a 4-point rating scale	up to 7 days after last drug administration