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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: PEG 400

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PEG 400; multiple rising doses	Drug: PEG 400
PLACEBO_COMPARATOR: Placebo	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events		up to 7 days after last drug administration
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
Assessment of global tolerability by the investigator on a 4-point rating scale		up to 7 days after last drug administration

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (ACTUAL): March 1, 2002

Study Registration Dates

• First Submitted: October 8, 2014
• First Submitted That Met QC Criteria: October 8, 2014
• First Posted (ESTIMATE): October 9, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 9, 2014
• Last Update Submitted That Met QC Criteria: October 8, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: 352.2030