Optimising the Propranolol Block Model

• Status: Completed
• Trial end date: 2007-10-26
• Target enrollment: 0
• Participant gender: All

Summary

Optimising the propranolol block model

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Albuterol; Ipratropium; Propranolol

Criteria

Inclusion Criteria:

• Healthy adult male 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:

• 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