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

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: PEG 400
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02260076
352.2030

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

64 participants in 2 patient groups, including a placebo group

PEG 400
Experimental group
Description:
multiple rising doses
Treatment:
Drug: PEG 400
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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