Comparing Two Respiratory Drugs When Used In Combination And Separately From A Novel Inhaler Device In Healthy Subjects

NCT00538057 | Completed Phase 1

• 1 other identifier: HZA105871
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A combination of the corticosteroid GW685698X and the long-acting ß2-agonist GW642444M is being developed for once daily administration for the maintenance treatment of asthma and COPD. GW642444M and GW685698X will be simultaneously co-administered from a single device and compared with GW642444M and GW685698X administered separately in order to determine whether co-administration affects the safety, tolerability, pharmacodynamic and/or pharmacokinetics of either compound.

Conditions

Asthma

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (5)

• Maximum heart rate

  over 4 hours after dosing.

• Blood pressure

  changes over 12 hours.

• Electrocardiogram

  changes over 12 hours.

• Change in peak expiry flow rate

  changes over 24 hours.

• Change in serum cortisol concentration

  changes over 24 hours.

Secondary Outcomes (3)

• Change in plasma drug concentration (AUC, Cmax, t1/2, tmax)

  over 48 hours after dosing.

• Change in blood potassium levels

  within 4 hours of drug dosing.

• Mean heart rate

  over 4 hours after dosing

Study Arms (1)

arm 1

EXPERIMENTAL

study drug

Drug: GW685698X & GW642444M

Interventions

GW685698X & GW642444M DRUG

study drug

arm 1

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged between 18 and 60 years.
• Male subjects or female subjects of non child bearing potential.
• Body weight at least 50 kg and BMI within the range of 19-31 kg/m2 inclusive.
• No significant abnormality from ECG at screening.
• FEV1 at least 90% predicted and FEV1 / FVC ratio at least 0.7 at screening.
• Current non-smokers who have not used any tobacco products in the 12 month period preceding the screening visit and have a pack history of equal to or less than 5 pack years.

You may not qualify if:

• Systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
• The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
• Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
• Liver function tests (AST, ALT or ALP) greater than 1.5 of the upper limit of laboratory reference range.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
• History of milk protein allergy.
• The subject has taken prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is the longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Sponsor the medication will not interfere with the study procedures or compromise subject safety.
• The subject has taken oral corticosteroids less than 8 weeks before the screening visit
• The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit
• History of alcohol/drug abuse or dependence within 12 months of the study.
• The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• The subject has donated a unit (450mL) of blood within the previous 16 weeks or intends to donate within 16 weeks after completing the study.
• A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
• The subject has tested positive for HIV antibodies.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, Sydney, New South Wales, 2031, Australia

Location

Related Publications (2)

• This study has not been published in the scientific literature.

  BACKGROUND

• Kempsford R, Allen A, Bareille P, Hamilton M, Cheesbrough A. The pharmacodynamics, pharmacokinetics, safety and tolerability of inhaled fluticasone furoate and vilanterol administered alone or simultaneously as fluticasone furoate/vilanterol. Clin Pharmacol Drug Dev. 2015 Jan;4(1):2-11. doi: 10.1002/cpdd.160. Epub 2014 Dec 5.

  PMID: 27127998 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
• Results for study HZA105871 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: October 2, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: August 4, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)