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

NCT02260076 | Completed Phase 1

• 1 other identifier: 352.2030
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

PEG 400

EXPERIMENTAL

multiple rising doses

Drug: PEG 400

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PEG 400 DRUG

PEG 400

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 %

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

polyethylene glycol 400

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 9, 2014
• Study Start: September 1, 2001
• Primary Completion: March 1, 2002
• Last Updated: October 9, 2014

Record last verified: 2014-10