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Propranolol Enabling Study
This study has been completed.
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00549120
  Purpose

Propranolol Enabling Study


Condition Intervention
Healthy Subjects
Drug: propranolol

Drug Information available for: Propranolol Dexpropranolol Propranolol hydrochloride
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: A Study to Optimise the Propranolol Block Model for Assessment of the Pharmacological Activity of Bronchodilators in Healthy Volunteers.

Further study details as provided by GlaxoSmithKline:

Enrollment: 16
Study Start Date: August 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult males or female aged between 18 and 50 years.
  • Body mass index within the range 19-29.9 kilograms/metre2
  • Forced Expiratory Volume in 1 second (FEV1) >80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio > 0.7
  • The subject has an increase in sGAW of >% over pre-dose baseline within 2 h of administration of 400 ug salbutamol by MDI inhaler at screening or in the 3 months before screening.
  • subject has an increase in sGaw of ?25% over pre-dose baseline within 2 h following 40 ug ipratropium bromide at screening or in the 3 months before screening
  • subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of < 10 pack years.

Exclusion criteria:

  • who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
  • history of respiratory disease
  • significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening >450msec on an individual ECG or a PR interval outside the range 120-210 msec
  • supine mean heart rate outside the range 45-90 beats per minute (bpm) at screening.
  • subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
  • subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort.
  • subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 1 month
  • infected with the Hepatitis B, Hepatitis C, or HIV virus
  • subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549120

Locations
United Kingdom
GSK Investigational Site
London, United Kingdom
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD MDsc FFPM GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: MAB104954
Study First Received: October 23, 2007
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00549120  
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by GlaxoSmithKline:
B-agonist,
b-antagonist,
propranolol

Study placed in the following topic categories:
Propranolol
Healthy

Additional relevant MeSH terms:
Vasodilator Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009