Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects

NCT01299558 | Completed Phase 1

• 1 other identifier: 102934
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being done to look at the absolute bioavailability of fluticasone furoate and GW642444 inhalation powder when administered in healthy subjects. Bioavailability is determined by measuring the amount of the dose of inhaled medication that reaches the circulation; the amount of inhaled fluticasone furoate and GW642444 powder will be compared to the medication administered intravenously (where bioavailability is 100%).

Conditions

Asthma

Keywords

pharmacokinetics; GW642444; absolute bioavailability; healthy subjects; fluticasone furoate; GW685698

Outcome Measures

Primary Outcomes (1)

• Absolute bioavailability of FF and GW642444 following single dose of FF/GW642444M Inhalation Powder; determined by measuring the amount of the dose of inhaled medication that reaches the circulation compared to the medication administered intravenously

  Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks

Secondary Outcomes (5)

• Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax, and MRT for all treatments. In addition, volume of distribution (V) and plasma clearance (CL) for intravenous administrations and mean absorption time (MAT) for inhaled treatments

  Up to 48hr PK sampling periods profiles on 3 separate occasions over a total period of up to 5 weeks

• Number of Participants with clinically significant changes to Vital Signs as a measure of Safety and Tolerability

  Approximately 9 weeks for each subject

• Number of Participants with clinically significant changes to 12-lead ECG Tests as a measure of Safety and Tolerability

  Approximately 9 weeks for each subject

• Number of Participants with clinically significant changes to Clinical Laboratory Tests as a measure of Safety and Tolerability

  Approximately 9 weeks for each subject

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  Approximately 9 weeks for each subject

Study Arms (3)

Treatment period 1

OTHER

Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder given once daily in the morning on Day 1 of Treatment period 1

Drug: fluticasone furoate//GW642444

Treatment Period 2

OTHER

Single IV dose of FF (250mcg) given over 20 mins on Day 1 of Treatment period 2

Drug: fluticasone furoate

Treatment Period 3

OTHER

Single IV dose of GW642444M (55mcg) given over 60 mins on Day 1 of Treatment period 3

Drug: GW642444

Interventions

fluticasone furoate//GW642444 DRUG

Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning

Treatment period 1

fluticasone furoate DRUG

Single IV dose of FF (250mcg)

Treatment Period 2

GW642444 DRUG

Single IV dose of GW642444 (55mcg)

Treatment Period 3

Eligibility Criteria

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

You may qualify if:

• Healthy male or female between 18 and 64 years of age inclusive
• Body mass index (BMI) within the range 18.5-29 0 kg/m2 (inclusive)
• Subjects who are current non-smokers
• AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
• QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block, based on a single ECG value, or an average from three ECGs obtained over a brief recording period
• No significant abnormality on the Holter ECG at screening
• FEV1 ≥ 85% predicted at screening.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
• Subjects who are able to use the inhalation device satisfactorily

You may not qualify if:

• As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg
• Any history of breathing problems in adult life
• Pregnant or lactating females
• The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
• Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit
• Subjects with recent history (within 6 months) of pneumonia
• 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 investigator or GSK Medical Monitor, contraindicates their participation
• Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the new powder inhaler (i.e., lactose or magnesium stearate)
• History of milk protein allergy
• Use of 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 longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor 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 an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Related Links

• Results for study 102934 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Asthma

Interventions

fluticasone furoate

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: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2010
• First Posted: February 18, 2011
• Study Start: May 17, 2010
• Primary Completion: July 15, 2010
• Study Completion: July 15, 2010
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)