The Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics

A Randomised, Single and Repeat Dose, Double-blind, Placebo Controlled Study to Assess the Safety and Tolerability of GW805858 in Healthy Volunteers and Mild Asthmatics

This study will be the First Time in Human Study (FTIH) aiming to assess the safety and tolerability of GW805858 for both single and repeat dose. The study also aims to assess safety and tolerability in mild asthmatic subjects as well as healthy volunteers.

Study Overview

• Status: Terminated
• Conditions: Asthma
• Intervention / Treatment: Drug: GW805858; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW20 0NE
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or women of non-child bearing potential, aged between 18 and 60 years of age inclusive.
• Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m2 inclusive.
• The subject is a current non-smoker who has not used any tobacco products in the last year.
• A signed and dated written informed consent is obtained for the subject.
• The subject is able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions.
• If asthmatic, the subject must be a clinically stable asthmatic.

Exclusion Criteria:

• The subject has a history of allergy to ingredients within the inhaler.
• The subject has received an investigational drug or participated in any other research trial within 30 days, prior to the first dose of current study medication.
• The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days prior to the first dose of study medication.
• The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female.
• The subject has any history of breathing problems (e.g. history of asthmatic symptoms).
• The subject is infected with the hepatitis B, hepatitis C, or HIV virus.
• The subject has had a respiratory tract infection or worsening of asthma within 4 weeks of the start of the study.
• The subject has a past or present disease, which as judged by the Investigator, may affect the outcome of this study.
• The subject has a history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxia seizures.
• The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study.
• The subject is unable to abstain from other drugs that may interfere with the conduct of the study.
• The subject has ongoing rhinitis that requires treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects receiving treatment sequence 1: Part 1; Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using Metered Dose Inhaler (MDI).	Drug: GW805858; GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.; Drug: Placebo; Placebo MDI will be given to the subjects.
Experimental: Subjects receiving treatment sequence 2: Part 1; Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI.	Drug: GW805858; GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.; Drug: Placebo; Placebo MDI will be given to the subjects.
Experimental: Subjects receiving treatment sequence 1: Part 2; Eligible subjects will receive placebo followed by GW805858 with a starting dose of 150 micrograms administered using MDI.	Drug: GW805858; GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.; Drug: Placebo; Placebo MDI will be given to the subjects.
Experimental: Subjects receiving treatment sequence 2: Part 2; Eligible subjects will receive GW805858 with a starting dose of 150 micrograms followed by placebo administered using MDI.	Drug: GW805858; GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.; Drug: Placebo; Placebo MDI will be given to the subjects.
Experimental: Subjects receiving GW805858: Part 3; Eligible subjects will receive GW805858 1200 micrograms twice daily administered using MDI.	Drug: GW805858; GW805858 MDI will be given with dose of 150 micrograms per metered actuation and 120 actuations per inhaler. GW805858 MDI comprises a solution of GW805858 in a liquefied hydrofluoroalkane propellant (1,1,1,2-tetrafluoroethane) which is contained in an aluminium alloy can, internally coated with a specified fluoropolymer, fitted with a metering valve.
Experimental: Subjects receiving placebo: Part 3; Eligible subjects will receive placebo administered using MDI.	Drug: Placebo; Placebo MDI will be given to the subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability parameters will be compared between active and placebo treatment groups using summary statistics. No formal statistical analyses of the safety and tolerability data will be performed.	Up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Derived GW805858 and GW288967 PK parameters will be compared between active and placebo treatment groups using summary statistics.	Pre-dose, 5,20,30,45,60,90 minutes, 2,3,4,6,8,10,12,12.5,13,14, 24 hours Post-dose on Days 1 and 28.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2006
• Primary Completion (Actual): April 10, 2006
• Study Completion (Actual): April 10, 2006

Study Registration Dates

• First Submitted: March 27, 2007
• First Submitted That Met QC Criteria: March 28, 2007
• First Posted (Estimate): March 29, 2007

Study Record Updates

• Last Update Posted (Actual): September 29, 2017
• Last Update Submitted That Met QC Criteria: September 27, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: asthma; MDI; GW805858; surfactant
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: SF2105450

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No