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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00538057
First received: October 1, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
Asthma
Drug: GW685698X & GW642444M
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Four-way Crossover Study to Compare the Pharmacodynamics and Pharmacokinetics of GW685698X and GW642444M When Administered Separately and in Combination as a Single Dose From a Novel Dry Powder Device in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Maximum heart rate [ Time Frame: over 4 hours after dosing. ]
  • Blood pressure [ Time Frame: changes over 12 hours. ]
  • Electrocardiogram [ Time Frame: changes over 12 hours. ]
  • Change in peak expiry flow rate [ Time Frame: changes over 24 hours. ]
  • Change in serum cortisol concentration [ Time Frame: changes over 24 hours. ]

Secondary Outcome Measures:
  • Change in plasma drug concentration (AUC, Cmax, t1/2, tmax) [ Time Frame: over 48 hours after dosing. ]
  • Change in blood potassium levels [ Time Frame: within 4 hours of drug dosing. ]
  • Mean heart rate [ Time Frame: over 4 hours after dosing ]

Enrollment: 16
Study Start Date: October 2007
Study Completion Date: December 2007
Intervention Details:
    Drug: GW685698X & GW642444M
    Other Name: GW685698X & GW642444M
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
  • The subject has a positive pre-study urine drug screen.
  • Positive CO or alcohol breath test at screening or on admission to the Unit.
  • History of any adverse reaction including immediate or delayed hypersensitivity to any ICS, ß2-agonist or sympathomimetic drug. gefitinib or erlotinib) is permitted. Use of bevacizumab must have ended at least 40 days prior to date of first dose of study drug.
  • Any anti-cancer therapy (surgery, tumor embolization, chemotherapy, radiation therapy, immunotherapy, biological therapy, or hormonal therapy) currently or within 14 days prior to date of first dose of study drug.
  • Any ongoing toxicity from prior anti-cancer therapy that is greater than Grade 1 and/or that is progressing in severity.
  • Known immediate or delayed hypersensitivity reaction or idiosyncracy to drugs chemically related to pazopanib.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538057

Locations
Australia, New South Wales
GSK Investigational Site
Randwick, Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00538057     History of Changes
Other Study ID Numbers: HZA105871
Study First Received: October 1, 2007
Last Updated: May 31, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
Healthy volunteers

ClinicalTrials.gov processed this record on September 29, 2014